Trial Outcomes & Findings for Gefitinib in Treating Patients Who Are Undergoing Surgery and/or Radiation Therapy for Locally Advanced or Recurrent Squamous Cell Skin Cancer (NCT NCT00126555)

Last Updated: 2019-08-30

Results Overview

Number of participants out of total participants with progression following two 30 day courses of Gefitinib. Tumor response evaluated by Response Evaluation Criteria in Solid Tumors by physical exam, computed tomography (CT) or Magnetic Resonance Imaging (MRI). Progressive disease defined as determined as response to Gefitinib induction therapy: Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants restaged on days 15 and 60 of treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Baseline to 60 days, up to 2 courses of induction therapy

Results posted on

2019-08-30

Participant Flow

Recruitment Period: April 08, 2005 to March 13, 2008. All participants were recruited at the University of Texas (UT) MD Anderson Cancer Center.

Of the 23 participants enrolled, one participant who was not evaluable for response withdrew before beginning treatment and is included the study demographics.

Participant milestones

Participant milestones
Measure	Gefitinib, Radiotherapy, Surgery Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
Overall Study STARTED	23
Overall Study Stratum 1- Resectable	18
Overall Study Stratum 2- Unresectable	4
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Gefitinib, Radiotherapy, Surgery Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	2
Overall Study Progressive Disease	3

Baseline Characteristics

Gefitinib in Treating Patients Who Are Undergoing Surgery and/or Radiation Therapy for Locally Advanced or Recurrent Squamous Cell Skin Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefitinib, Radiotherapy, Surgery n=23 Participants Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 60 days, up to 2 courses of induction therapy

Outcome measures

Outcome measures
Measure	Gefitinib, Radiotherapy, Surgery n=22 Participants Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase. Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase.	Patients Received the Escalated Gefitinib Dose Patients treated induction gefitinib evaluated as Stable Disease at 15 days, patients received the escalated gefitinib dose for 45 days, total of 60 days.	Patients Treated Radiation and Concurrent Gefitinib Unresectable patients treated concomitant gefitinib with radiotherapy	Maintenance Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
Early Progression Rate	31.8 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: Up to 100 days

Completion Induction phase, participants are evaluated for clinical response and resectability. Resectable participants who had achieved at least stable disease and received surgery followed by radiation. Unresectable participants who had achieved at least stable disease received concomitant radiation/Gefitinib.

Outcome measures

Outcome measures
Measure	Gefitinib, Radiotherapy, Surgery n=17 Participants Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase. Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase.	Patients Received the Escalated Gefitinib Dose n=6 Participants Patients treated induction gefitinib evaluated as Stable Disease at 15 days, patients received the escalated gefitinib dose for 45 days, total of 60 days.	Patients Treated Radiation and Concurrent Gefitinib n=3 Participants Unresectable patients treated concomitant gefitinib with radiotherapy	Maintenance Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. Complete Response (CR)	4 Participants	1 Participants	0 Participants	—
Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. Partial Response (PR)	5 Participants	0 Participants	2 Participants	—
Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. Stable Disease (SD)	5 Participants	3 Participants	1 Participants	—
Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation. Progressive Disease (PD)	3 Participants	2 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Up to 5 years

Population: Of 23 enrolled, 1 withdrew, 2 went off study during induction for adverse events and 3 had progressive disease. Of 17 continuing to clinical response assessment (11 on 250 mg/day Induction dose \& 6 to 500 mg/day dose escalation), 12 were resectable (2 refused), 2 unresectable and 3 had disease progression leaving only 6 for maintenance.

Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.

Outcome measures

Outcome measures
Measure	Gefitinib, Radiotherapy, Surgery n=11 Participants Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase. Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase.	Patients Received the Escalated Gefitinib Dose n=6 Participants Patients treated induction gefitinib evaluated as Stable Disease at 15 days, patients received the escalated gefitinib dose for 45 days, total of 60 days.	Patients Treated Radiation and Concurrent Gefitinib n=17 Participants Unresectable patients treated concomitant gefitinib with radiotherapy	Maintenance n=6 Participants Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Rash/acneiform	7 participants	4 participants	2 participants	4 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Fatigue	11 participants	5 participants	3 participants	2 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Dry skin	2 participants	2 participants	1 participants	3 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Pruitis	4 participants	2 participants	0 participants	1 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Rash/desquamation	4 participants	2 participants	1 participants	1 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Anorexia	1 participants	2 participants	3 participants	3 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Diarrhea	10 participants	0 participants	0 participants	6 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Nausea	6 participants	1 participants	3 participants	0 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Vomiting	3 participants	0 participants	1 participants	0 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Elevation of alanine transferase (ALT)	3 participants	2 participants	0 participants	0 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Elevation of asparagine transferase (AST)	4 participants	2 participants	1 participants	1 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Elevation of Creatinine	2 participants	0 participants	0 participants	0 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Abdominal pain	2 participants	0 participants	0 participants	1 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Dry eyes	1 participants	0 participants	1 participants	0 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3) Ocular/visual, other	0 participants	1 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Gefitinib, Radiotherapy, Surgery n=11 Participants Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase. Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase.	Patients Received the Escalated Gefitinib Dose n=6 Participants Patients treated induction gefitinib evaluated as Stable Disease at 15 days, patients received the escalated gefitinib dose for 45 days, total of 60 days.	Patients Treated Radiation and Concurrent Gefitinib n=17 Participants Unresectable patients treated concomitant gefitinib with radiotherapy	Maintenance n=6 Participants Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Blurred vision	1 participants	0 participants	1 participants	1 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Allergic reaction	1 participants	0 participants	0 participants	1 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Anemia	3 participants	1 participants	2 participants	3 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Weight Loss	1 participants	0 participants	1 participants	1 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Alopecia	0 participants	0 participants	1 participants	1 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Taste alteration	1 participants	0 participants	0 participants	0 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Epistaxis	1 participants	0 participants	0 participants	0 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Infection	0 participants	1 participants	0 participants	0 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Elevated BUN	1 participants	0 participants	0 participants	1 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Elevated White Blood Cell Count (CBC)	1 participants	0 participants	0 participants	0 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Insomnia	0 participants	0 participants	0 participants	1 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Depression	0 participants	0 participants	0 participants	1 participants
Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3) Tooth pain	1 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: One participant of 23 enrolled withdrew prior to treatment.

Number participants with response defined by RECIST: Complete Response (CR): Disappearance all disease; No new lesions/non-evaluable disease; Responders on none/only maintenance doses of corticosteroids. Partial Response (PR): \>/= 50% decrease under baseline in sum products perpendicular diameters of measurable lesions; No progression evaluable disease/new lesions; Responders on same/decreasing doses dexamethasone \& stable/improved neurological exams. Stable/No Response (SD): Not qualify for CR, PR, or progression; requires minimum 12 weeks duration; Responders on same/decreasing doses dexamethasone \& stable/improved neurological exams. Progression (PD): 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), OR clear worsening any evaluable disease, OR appearance any new lesion/site, OR failure to return due to death/deteriorating condition. All measurable/evaluable sites assessed using same baseline techniques.

Outcome measures

Outcome measures
Measure	Gefitinib, Radiotherapy, Surgery n=22 Participants Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase. Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase.	Patients Received the Escalated Gefitinib Dose Patients treated induction gefitinib evaluated as Stable Disease at 15 days, patients received the escalated gefitinib dose for 45 days, total of 60 days.	Patients Treated Radiation and Concurrent Gefitinib Unresectable patients treated concomitant gefitinib with radiotherapy	Maintenance Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Complete Response (CR)	4 participants	—	—	—
Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Partial Response (PR)	6 participants	—	—	—
Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Stable Disease (SD)	5 participants	—	—	—
Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Progressive Disease (PD)	7 participants	—	—	—

SECONDARY outcome

Timeframe: From study entry to first documented local recurrence or last patient contact, assessed up to 5 years

Population: Two participants did not complete study treatment (Surgery + Radiotherapy) of 17 progressed and was removed from the study.

Outcome measures

Outcome measures
Measure	Gefitinib, Radiotherapy, Surgery n=15 Participants Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase. Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase.	Patients Received the Escalated Gefitinib Dose n=15 Participants Patients treated induction gefitinib evaluated as Stable Disease at 15 days, patients received the escalated gefitinib dose for 45 days, total of 60 days.	Patients Treated Radiation and Concurrent Gefitinib Unresectable patients treated concomitant gefitinib with radiotherapy	Maintenance Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
Frequency and Timing of Local and Distant Failures Dermal metastases	0 participants	0 participants	—	—
Frequency and Timing of Local and Distant Failures Local recurrence	2 participants	0 participants	—	—
Frequency and Timing of Local and Distant Failures unknown	1 participants	5 participants	—	—
Frequency and Timing of Local and Distant Failures No Evidence of Disease (NED)	12 participants	5 participants	—	—
Frequency and Timing of Local and Distant Failures Living with disease	0 participants	0 participants	—	—
Frequency and Timing of Local and Distant Failures Died of their disease (DOD)	0 participants	2 participants	—	—
Frequency and Timing of Local and Distant Failures Died from other causes	0 participants	3 participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Samples were not available from all participants because the protocol specified that consenting to tissue biopsies was optional. Sample size was too small to determine EGFR-proliferative responses activated by the AKT pathway;hence, monitoring of the status of activated phospho-AKT as an independent marker of EGFR activation could not be performed.

Samples were not available from all participants because the protocol specified that consenting to tissue biopsies was optional. In addition, some participants presented with regional recurrences, which were not superficially accessible. The sample size was too small to determine the EGFR-proliferative responses activated by the AKT pathway; hence, the monitoring of the status of activated phospho-AKT as an independent marker of EGFR activation could not be performed.

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: Following 60 days of Gefitinib induction treatment

Treatment received following two 30-day cycles (60 days) of 250 mg gefitinib given by mouth daily. Participant treatment reported as percentage of total treated participants out of total treated.

Outcome measures

Outcome measures
Measure	Gefitinib, Radiotherapy, Surgery n=22 Participants Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase. Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase.	Patients Received the Escalated Gefitinib Dose Patients treated induction gefitinib evaluated as Stable Disease at 15 days, patients received the escalated gefitinib dose for 45 days, total of 60 days.	Patients Treated Radiation and Concurrent Gefitinib Unresectable patients treated concomitant gefitinib with radiotherapy	Maintenance Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
Participant Treatment Following Induction Therapy Surgery Alone	11.8 percentage of participants	—	—	—
Participant Treatment Following Induction Therapy Definitive Radiation	17.6 percentage of participants	—	—	—
Participant Treatment Following Induction Therapy Radiation and Concurrent Gefitinib	11.8 percentage of participants	—	—	—
Participant Treatment Following Induction Therapy Surgery, Post-Op Radiation & Concurrent Gefitinib	47 percentage of participants	—	—	—

Adverse Events

Gefitinib, Radiotherapy, Surgery

Serious events: 5 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gefitinib, Radiotherapy, Surgery n=22 participants at risk Resectable Strata: Induction Gefitinib (60 days), Surgery followed 3-6 weeks later by daily Radiotherapy 5 days a week for approximately 6-7 weeks then after 4 weeks restart Maintenance Gefitinib for up to additional 12 months post radiation. Unresectable Strata: Concomitant Radiation/Gefitinib and post-radiation (or post-surgery if surgery is indicated) Gefitinib. Daily Radiotherapy 5 days a week for approximately 6-7 weeks concurrent with Maintenance Gefitinib dose daily up to 12 months. Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase.
Metabolism and nutrition disorders Alanine aminotransferase increased	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Nervous system disorders Confusion	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Dehydration	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Nervous system disorders Depression	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Dermatitis radiation	22.7% 5/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Diarrhea	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Dry mouth	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Dysphagia	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
General disorders Fatigue	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hyponatremia	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Cardiac disorders Hypotension	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Infections and infestations Infection with Grade 3 or 4 neutrophils	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
General disorders Insomnia	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Blood and lymphatic system disorders Lymphocyte count decreased	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Mucositis oral	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Ear and labyrinth disorders Pain of skin, Ear	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Rash acneiform	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Toothache	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
General disorders Tumor Pain	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.

Other adverse events

Other adverse events
Measure	Gefitinib, Radiotherapy, Surgery n=22 participants at risk Resectable Strata: Induction Gefitinib (60 days), Surgery followed 3-6 weeks later by daily Radiotherapy 5 days a week for approximately 6-7 weeks then after 4 weeks restart Maintenance Gefitinib for up to additional 12 months post radiation. Unresectable Strata: Concomitant Radiation/Gefitinib and post-radiation (or post-surgery if surgery is indicated) Gefitinib. Daily Radiotherapy 5 days a week for approximately 6-7 weeks concurrent with Maintenance Gefitinib dose daily up to 12 months. Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase.
Gastrointestinal disorders Abdominal pain	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Alanine aminotransferase increased	22.7% 5/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Alkaline phosphatase increased	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Immune system disorders Allergic reaction	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Immune system disorders Allergic rhinitis	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Alopecia	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Blood and lymphatic system disorders Anemia	59.1% 13/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Anorexia	27.3% 6/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Nervous system disorders Anxiety	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Aspartate aminotransferase increased	45.5% 10/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Cardiac disorders Atrial fibrillation	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Musculoskeletal and connective tissue disorders Back pain	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Blood and lymphatic system disorders White Blood Count Elevated	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Blood bilirubin increased	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Eye disorders Blurred vision	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Chest wall pain	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Eye disorders Conjunctivitis	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Constipation	27.3% 6/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Cough	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Creatinine increased	18.2% 4/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Dehydration	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Nervous system disorders Depression	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Dermatitis radiation	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Diarrhea	68.2% 15/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Nervous system disorders Dizziness	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Eye disorders Dry eye	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Dry mouth	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Dry skin	27.3% 6/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Dysgeusia	18.2% 4/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Dysphagia	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Ear and labyrinth disorders Ear Pain/Pressure	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Edema face	18.2% 4/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
General disorders Epistaxis	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Erythema multiforme	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Ear and labyrinth disorders External ear pain	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Eye disorders Eye Erythema Irritation	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Eye disorders Eye Pain	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
General disorders Facial pain	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
General disorders Fatigue	59.1% 13/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
General disorders Fever	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Gastritis	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
General disorders General disorders and administration site conditions	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Gingival pain	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Nervous system disorders Headache	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hypercalcemia	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hyperglycemia	50.0% 11/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hyperkalemia	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Cardiac disorders Hypertension	31.8% 7/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hyperuricemia	22.7% 5/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hypoalbuminemia	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hypocalcemia	22.7% 5/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hypoglycemia	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hypokalemia	18.2% 4/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hypomagnesemia	18.2% 4/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hyponatremia	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hypophosphatemia	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Metabolism and nutrition disorders Hypothyroidism	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Infections and infestations Infection	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
General disorders Insomnia	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Investigations BUN Elevation/Change	31.8% 7/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Blood and lymphatic system disorders Lymphadenitis	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Blood and lymphatic system disorders Lymph node pain	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Blood and lymphatic system disorders Lymphopenia	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Mucositis oral	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Nail loss	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Nausea	59.1% 13/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Oral Pain	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Pain of skin	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Nervous system disorders Peripheral sensory neuropathy	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Eye disorders Photophobia	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Blood and lymphatic system disorders Platelet count decreased	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Pruritus	50.0% 11/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Rash acneiform	50.0% 11/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Rash maculo-papular	22.7% 5/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Rectal pain	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Sinus disorder	13.6% 3/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Skin ulceration	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Stomach pain	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
General disorders Tumor pain	31.8% 7/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Renal and urinary disorders Urinary tract infection	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Immune system disorders Urticaria	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Gastrointestinal disorders Vomiting	27.3% 6/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
General disorders Weight loss	18.2% 4/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Blood and lymphatic system disorders White blood cell decreased	4.5% 1/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.
Skin and subcutaneous tissue disorders Wound dehiscence	9.1% 2/22 • Adverse event reporting up to 30 days after last dose investigational agent, up to 12 months following radiotherapy. Active study period June 2005 to September 2008. One participant in Stratum I out of total 23 enrolled participants withdrew prior to any treatment and is not included in adverse event reporting.

Additional Information

Randal S. Weber, MD / Head & Neck Surgery

University of Texas MD Anderson Cancer Center

Phone: 7137927734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60