Trial Outcomes & Findings for Iressa Study in Patients With Salivary Gland Cancer (NCT NCT00509002)

Last Updated: 2017-11-24

Results Overview

The modified Response Evaluation Criteria in Solid tumors (RECIST) criteria was used for objective tumor response assessment. Complete Response (CR): Disappearance all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): \>20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or \> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Response rate estimated by Gehan's Phase II clinical trial design.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal

Results posted on

2017-11-24

Participant Flow

Recruitment Period: May 2004 to October 2006. All recruitment done at The University of Texas MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Gefitinib Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
Overall Study STARTED	37
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Iressa Study in Patients With Salivary Gland Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefitinib n=37 Participants Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	5 Participants n=5 Participants
Race (NIH/OMB) White	29 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	37 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal

Outcome measures

Outcome measures
Measure	Gefitinib n=37 Participants Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy Inevaluable	6 Participants
Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy Progressive Disease	13 Participants
Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy Complete Response	0 Participants
Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy Partial Response	0 Participants
Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy Stable Disease	18 Participants

Adverse Events

Gefitinib

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gefitinib n=37 participants at risk Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
Gastrointestinal disorders Anorexia	29.7% 11/37 • Number of events 11 • Adverse events collected every four weeks during treatment at regular assessment, participation expected up to 12 months.
Gastrointestinal disorders Diarrhea	81.1% 30/37 • Number of events 30 • Adverse events collected every four weeks during treatment at regular assessment, participation expected up to 12 months.
Skin and subcutaneous tissue disorders Dry skin	18.9% 7/37 • Number of events 8 • Adverse events collected every four weeks during treatment at regular assessment, participation expected up to 12 months.
General disorders Fatigue	40.5% 15/37 • Number of events 16 • Adverse events collected every four weeks during treatment at regular assessment, participation expected up to 12 months.
Skin and subcutaneous tissue disorders Rash/desquamation	21.6% 8/37 • Number of events 8 • Adverse events collected every four weeks during treatment at regular assessment, participation expected up to 12 months.

Additional Information

George R Blumenschein Jr, MD, Professor, Thoracic/Head & Neck Med. Oncology

The University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place