Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer

You may be eligible if

• 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