Gefitinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or 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: Phase I (closed as of 5/30/02): Histologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective Phase II: Histologically confirmed metastatic or unresectable colorectal adenocarcinoma Measurable disease or assessable but nonmeasurable disease (including ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses (not followed by CT scan/MRI), or cystic lesions) Disease characterized only by elevated serum tumor marker allowed No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: More than 3 months 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 mg/dL AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal 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 ongoing or active infection No peripheral neuropathy No prior allergic reactions to compounds of similar chemical or biologic composition to gefitinib or other study agents No other concurrent uncontrolled illness No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow or stem cell support with high-dose chemotherapy At least 24 hours since prior colony-stimulating growth factors Chemotherapy: See Biologic therapy At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No more than 3 prior chemotherapy regimens Endocrine therapy: At least 2 weeks since prior hormonal therapy except megestrol for anorexia/cachexia Radiotherapy: No prior pelvic or whole abdominal radiotherapy At least 4 weeks since other prior radiotherapy and recovered Surgery: At least 4 weeks since prior major surgery (e.g., laparotomy) and recovered Other: At least 4 weeks since prior investigational therapy No other concurrent investigational or commercial anticancer agents No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Stanford Cancer Center at Stanford University Medical Center