Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Mucinous Adenocarcinoma of the Colon
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Colon
Eligibility Criteria
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
Sites / Locations
- Abramson Cancer Center of The University of Pennsylvania
Arms of the Study
Arm 1
Experimental
Treatment (irinotecan, gefitinib, leucovorin, fluorouracil)
Patients receive oral gefitinib daily beginning on day 1, irinotecan IV over 90 minutes on days 1 and 15, and leucovorin calcium IV over 2 hours and fluorouracil IV over 3-5 seconds followed by a 22-hour infusion on days 1, 2, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.