ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed colorectal adenocarcinoma
• •* Metastatic or locally advanced disease
• •* Not amenable to curative therapy
• •Documentation of disease progression within the past 6 months
• •Previously treated with fluoropyrimidine- and irinotecan-based chemotherapy (including capecitabine) administered either concurrently (no more than 2 regimens) or sequentially (no more than 3 regimens) for advanced disease
• •At least 1 unidimensionally measurable lesion
• •* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• •No known brain metastases
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •ECOG 0-2 OR
• •Karnofsky 60-100%
• •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/ALT no greater than 3 times ULN (5 times ULN if liver metastasis present)
• •Renal:
• •Creatinine no greater than 1.5 times ULN OR
• •Creatinine clearance at least 60 mL/min
• •Cardiovascular:
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •Ophthalmic:
• •No significant ophthalmic conditions, including:
• •* Severe dry-eye syndrome
• •* Keratoconjunctivitis sicca
• •* Sjogren's syndrome
• •* Severe-exposure keratopathy
• •* Disorders that may increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
• •Other:
• •Able to take oral gefitinib
• •No other uncontrolled concurrent illness
• •No ongoing or active infection
• •No psychiatric illness or social situation that would preclude study participation
• •No prior gastrointestinal disorders (e.g., malabsorption syndrome)
• •No prior allergic reactions attributed to compounds of similar chemical or biological composition to gefitinib
• •No other prior malignancy except carcinoma in situ of the cervix, nonmelanoma skin cancer, or other cancer from which the patient has been free of evident disease for more than 5 years and/or has less than a 20-30% estimated likelihood of recurrence
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •See Disease Characteristics
• •At least 30 days since prior chemotherapy and recovered
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •Not specified
• •Surgery:
• •No prior gastric resection
• •Other:
• •No other prior therapy for advanced disease
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No other concurrent investigational or commercial agents or therapies for the malignancy