Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer

Inclusion Criteria:

Histologically confirmed advanced (stage IV) or recurrent adenocarcinoma of the colon or rectum
Must have available tissue for immunohistochemical analysis

At least one unidimensionally measurable lesion

At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
Tumor marker (carcinoembryonic antigen) elevation alone is insufficient for study entry
No known brain metastases
Performance status - ECOG 0-2
Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST less than 2 times ULN (5 times ULN if liver involvement of tumor)
Creatinine no greater than 1.5 times ULN
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Fertile patients must use effective contraception
HIV negative
No other severe or uncontrolled concurrent illness that would adversely impact the safety or efficacy of study therapy
No ongoing or active infection
No other prior malignancy unless curatively treated and no evidence of recurrence
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gefitinib
No psychiatric illness or social situation that would preclude study compliance
No prior chemotherapy for advanced disease
More than 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
More than 4 weeks since prior radiotherapy and recovered
At least 6 months since prior adjuvant therapy
No prior epidermal growth factor receptor inhibitor
No other concurrent investigational agents
No other concurrent anticancer therapy
No concurrent phenytoin, carbamazepine, barbiturates, rifampin, rifapentine, oxacarbazepine, modafinil, griseofulvin, or Hypericum perforatum