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

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