Gefitinib in Treating Patients With Recurrent Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of recurrent metastatic colorectal cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of gefitinib in treating patients who have recurrent metastatic colorectal cancer.

Detailed Description
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OBJECTIVES: Determine the 4-month progression-free survival rate in patients with recurrent metastatic colorectal adenocarcinoma treated with gefitinib. Determine the objective tumor response rate, progression, and overall survival of patients treated with this drug. Determine the toxicity of this drug in these patients. OUTLINE: This is a randomized, double-blind study. Patients are stratified according to ECOG performance status (0-1 vs 2), baseline serum CEA (less than 5 mg/L vs at least 5 mg/L), and number of metastatic sites (1 vs 2 or more). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral gefitinib once daily (twice daily on day 1 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive a higher dose of oral gefitinib as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Official Title
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A Randomized Phase II Trial of Two Dose Levels of ZD1839 (Iressa) (NSC 715055, IND 61187) in Patients With Recurrent Colorectal Adenocarcinoma

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: gefitinib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically proven adenocarcinoma of the colon or rectum Measurable disease Evidence of new or progressive metastatic disease within 6 months of last treatment Must have received prior systemic treatment with fluorouracil (and/or its analogs, with or without leucovorin calcium or levamisole) and irinotecan in the adjuvant or metastatic setting Metastatic tumor site accessible for biopsy No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN (5 times ULN if tumor involvement of the liver) Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No ongoing active or uncontrolled infections Other prior malignancies allowed provided prior therapy is discontinued and no evidence of disease No other uncontrolled illness or psychiatric illness/social situations that would preclude study Must be able to take and retain oral medications PRIOR CONCURRENT THERAPY: Biologic therapy: No prior signal transduction inhibitors (e.g., vascular endothelial growth factor-, vascular endothelial growth factor receptor-, and epidermal growth factor receptor-targeted agents) for colorectal cancer Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No other prior cytotoxic chemotherapy (e.g., oxaliplatin) for colorectal cancer Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: No other prior systemic therapy for colorectal cancer No other prior investigational or approved agents for colorectal cancer No other concurrent investigational agents No concurrent antiretroviral therapy for HIV-positive patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gefitinib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum