Trial Outcomes & Findings for Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer (NCT NCT00352105)

Results Overview

To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

60 participants

Primary outcome timeframe

at 1 year after start of treatment

Results posted on

2012-11-05

Participant Flow

Patients accrued between April 2003 and December 2007 from clinical facility

Participant milestones

Participant milestones
Measure	5-FU, Cisplatin, Radiation and Iressa Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	60
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	5-FU, Cisplatin, Radiation and Iressa Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Overall Study Death	5
Overall Study Withdrawal by Subject	5
Overall Study Lack of Efficacy	9
Overall Study Adverse Event	19
Overall Study Protocol Violation	2

Baseline Characteristics

Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5-FU, Cisplatin, Radiation and Iressa n=60 Participants Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Age Continuous	57 years STANDARD_DEVIATION 8 • n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	53 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	58 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	60 participants n=93 Participants

PRIMARY outcome

Timeframe: at 1 year after start of treatment

To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival

Outcome measures

Outcome measures
Measure	5-FU, Cisplatin, Radiation and Iressa n=60 Participants Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival	52 participants 4

PRIMARY outcome

Timeframe: 1 year

Population: 5 early deaths were not evaluable

1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.

Outcome measures

Outcome measures
Measure	5-FU, Cisplatin, Radiation and Iressa n=55 Participants Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Number of Participants With No Distant Metastatic Disease at 1 Year	54 participants 2

SECONDARY outcome

Timeframe: at 1 year after start of treatment

Population: 5 early deaths not evaluable

Number of Participants with No Local Disease at 1 Year. Local disease means that the cancer came back in the same site.

Outcome measures

Outcome measures
Measure	5-FU, Cisplatin, Radiation and Iressa n=55 Participants Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Number of Participants With No Local Disease at 1 Year	48 participants 3

SECONDARY outcome

Timeframe: at 1 year after start of treatment

Any toxicity greater than or equal to Grade 1= mild

Outcome measures

Outcome measures
Measure	5-FU, Cisplatin, Radiation and Iressa n=60 Participants Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity	60 participants

SECONDARY outcome

Timeframe: 3 years

Population: 5 early deaths were not evaluable

Complete response rate per RECIST Criteria (CTC V3)

Outcome measures

Outcome measures
Measure	5-FU, Cisplatin, Radiation and Iressa n=55 Participants Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.	42 participants

SECONDARY outcome

Timeframe: at 2 years after start of treatment

Outcome measures

Outcome measures
Measure	5-FU, Cisplatin, Radiation and Iressa n=60 Participants Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Number of Participants Who Completed 2 Years of Therapy	20 participants 7

Adverse Events

5-FU, Cisplatin, Radiation and Iressa

Serious events: 60 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	5-FU, Cisplatin, Radiation and Iressa n=60 participants at risk Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders >= Grade 3 dysphagia	68.3% 41/60 • For 2 years of the study
Gastrointestinal disorders >= Grade 3 mucositis	86.7% 52/60 • For 2 years of the study
Gastrointestinal disorders >=Grade 3:Nausea, vomiting	1.7% 1/60 • For 2 years of the study
General disorders Death	8.3% 5/60 • For 2 years of the study
Blood and lymphatic system disorders Neutropenia	76.7% 46/60 • For 2 years of the study
Renal and urinary disorders Renal Dysfunction	28.3% 17/60 • For 2 years of the study
Blood and lymphatic system disorders Thrombocytopenia	5.0% 3/60 • For 2 years of the study

Other adverse events

Other adverse events
Measure	5-FU, Cisplatin, Radiation and Iressa n=60 participants at risk Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Grade 1-2 :Nausea, vomiting	86.7% 52/60 • For 2 years of the study
Blood and lymphatic system disorders Grade 1-2 dysphagia	30.0% 18/60 • For 2 years of the study
Gastrointestinal disorders Grade 1-2 mucositis	11.7% 7/60 • For 2 years of the study

Additional Information

Dr. David Adelstein

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Phone: 216-444-9310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place