Capecitabine, Oxaliplatin, and Gefitinib in Treating Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed* colorectal cancer Metastatic disease The site of the primary tumor must have been confirmed endoscopically, radiologically, or surgically to be the colon or rectum NOTE: *Confirmation is not required for recurrent metastatic disease unless an interval of > 5 years has elapsed between the initial primary surgery and the development of metastases Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No CNS metastases PATIENT CHARACTERISTICS: Age 18 to 80 Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL (transfusion allowed) Hepatic AST and ALT ≤ 3 times upper limit of normal (ULN) Bilirubin ≤ ULN No unstable or uncompensated hepatic disease Renal Creatinine < 1.5 times ULN OR Creatinine clearance > 60 mL/min No unstable or uncompensated renal disease Cardiovascular No unstable or uncompensated cardiac disease Pulmonary No evidence of clinically active interstitial lung disease Asymptomatic patients with chronic stable radiographic changes are eligible No unstable or uncompensated respiratory disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No known hypersensitivity to gefitinib or any of its excipients No known hypersensitivity to platinum compounds, fluorouracil, or capecitabine No severe or uncontrolled systemic disease Able to receive oral medication No known dihydropyrimidine dehydrogenase (DPD) deficiency No known peripheral neuropathy ≥ grade 1 Absence of deep tendon reflexes as the sole neurological abnormality allowed No other significant clinical disorder or laboratory finding that would preclude study participation No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix (phase II only) PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 4 weeks since prior chemotherapy for metastatic colorectal cancer (phase I) No prior chemotherapy for metastatic disease (phase II) Prior fluorouracil and leucovorin calcium in the adjuvant setting allowed provided the last treatment was administered more than 6 months before the development of metastatic disease No prior irinotecan and oxaliplatin (phase II) Endocrine therapy Not specified Radiotherapy No concurrent radiotherapy for colorectal cancer Surgery See Disease Characteristics More than 4 weeks since prior major surgery (e.g., laparotomy) Other Recovered from all prior therapy (no unresolved chronic toxicity > grade 2) More than 4 weeks since prior investigational drugs No prior epidermal growth factor receptor inhibitor therapy (phase II) No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort) No other concurrent investigational drugs No other concurrent systemic therapy for colorectal cancer
Sites / Locations
- Roswell Park Cancer Institute