Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to potentially curative surgical resection Metastatic or locally recurrent disease Tumor in liver or lung accessible to needle biopsy by ultrasound or CT scan guidance At least 1 measurable lesion At least 20 mm by conventional techniques, including physical examination, CT scan, or MRI OR At least 10 mm by spiral CT scan Lesions on colonoscopic examination or barium studies, bone metastases, CNS lesions, and ascites are not considered measurable Failed prior therapy with fluorouracil, leucovorin calcium, and irinotecan given either sequentially or in combination No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No peripheral neuropathy greater than grade 1 No other concurrent uncontrolled illness that would preclude study No concurrent psychiatric illness or social situation that would preclude study No ongoing or active infection No prior allergic reaction to compounds of similar chemical or biologic composition to oxaliplatin or gefitinib No other concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless considered to be at less than 30% risk of relapse after completion of therapy PRIOR CONCURRENT THERAPY: Biologic therapy: No prior epidermal growth factor inhibitor At least 24 hours since prior colony-stimulating factors No concurrent colony-stimulating factors during first course of study therapy Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens for metastatic disease Prior adjuvant chemotherapy allowed At least 4 weeks since prior cytotoxic chemotherapy and recovered No prior cisplatin or oxaliplatin Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics At least 4 weeks since prior surgery Other: At least 30 days since prior investigational agents Recovered from prior therapy No concurrent anti-retroviral therapy for HIV No other concurrent investigational or commercial agents or therapies for malignancy
Sites / Locations
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Evanston Northwestern Health Care
- Ingalls Memorial Hospital
- LaGrange Memorial Hospital
- Loyola University Medical Center
- Oncology/Hematology Associates of Central Illinois, P.C.
- Central Illinois Hematology Oncology Center
- Fort Wayne Medical Oncology and Hematology, Inc.
- Memorial Hospital of South Bend
- Oncology Care Associates, P.L.L.C.
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Phase 2: Oxaliplatin plus ZD1839
Phase 2: Oxaliplatin alone
Phase I: Oxaliplatin with ZD1839
Oxaliplatin will be administered by IV infusion once every 21 days at a fixed dose of 130 mg/m2 and ZD1839 will be taken orally at a dose of 250 mg or 500 mg daily (as determined during phase 1). Subjects can continue to receive the combination for 6 cycles (each cycle is 21 days). After 6 cycles of the combination, subjects can continue to take ZD1839 alone until their cancer worsens.
Oxaliplatin will be administered by IV infusion once every 21 days at a fixed dose of 130 mg/m2 for up to 6 cycles. Each cycle will last 21 days.
Oxaliplatin will be administered by IV infusion once every 21 days at a fixed dose of 130 mg/m2. ZD1839 will be taken orally at a dose of 250 mg or 500 mg daily.