Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic 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 confirmed metastatic adenocarcinoma of the colon or rectum Bidimensionally measurable disease At least 2.0 x 2.0 cm Failed prior fluoropyrimidine and irinotecan chemotherapy in adjuvant or metastatic setting Must have had disease progression while receiving chemotherapy OR If received fluorouracil with or without irinotecan in adjuvant setting, must also have failed therapy with these agents in metastatic setting (unless manifesting metastatic disease during adjuvant therapy) No known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL Absolute neutrophil count at least 1,500/mm^3 WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2.5 ULN (5 times ULN if bone or liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV congestive heart failure No myocardial infarction within the past 6 months Gastrointestinal: No bowel obstruction No active uncontrolled malabsorption syndrome Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer No other active cancers, including stable disease on adjuvant therapy No other medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy At least 2 weeks since prior biologic therapy and recovered Chemotherapy: See Disease Characteristics No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease Monoclonal antibody (MOAB) therapy and antiangiogenic agents not included as prior cytotoxic chemotherapy At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: No prior total gastrectomy Other: No other concurrent investigational agents
Sites / Locations
- Memorial Sloan-Kettering Cancer Center