A Phase III, Randomized, Open-Label Multicenter, International Study Comparing The Combination Of SU5416/Irinotecan/5-Fluorouracil/Leucovorin Versus Irinotecan/Fluorouracil/Leucovorin Alone As First-Line Therapy Of Patient With Previously Untreated Metastatic Colorectal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum
Newly diagnosed or recurrent disease Measurable or evaluable metastatic disease that is
previously untreated No known brain or leptomeningeal metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 1.8
times upper limit of normal (ULN) SGOT no greater than 5 times ULN Alkaline phosphatase no
greater than 5 times ULN Lactate dehydrogenase no greater than 5 times ULN Renal:
Creatinine no greater than 1.5 times ULN Cardiovascular: No myocardial infarction within
the past 6 months No ongoing unstable angina No symptomatic congestive heart failure No
serious uncontrolled cardiac dysrhythmia No stroke within the past 6 months
Gastrointestinal: No active inflammatory bowel disease No significant bowel obstruction No
chronic diarrhea grade 2 or greater Other: HIV negative No AIDS-related illness No known
allergy to Cremaphor-containing products, irinotecan, fluorouracil, or to both warfarin
(or similar oral anticoagulants) and low-molecular weight heparin No other malignancy
within the past 5 years except nonmelanoma skin cancer No other severe acute or chronic
medical or psychiatric condition or laboratory abnormality that would preclude study Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior adjuvant
antibody therapy, immunotherapy, gene therapy, vaccine therapy, or cytokine therapy No
prior systemic biologic therapy for metastatic disease, including antibody therapy,
immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or angiogenesis inhibitors
(e.g., SU5416, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal
antibody) No concurrent antibody therapy, immunotherapy, gene therapy, vaccine therapy, or
angiogenesis inhibitors No concurrent sargramostim (GM-CSF) Chemotherapy: At least 6
months since prior adjuvant chemotherapy (e.g., fluorouracil, leucovorin calcium,
levamisole, irinotecan, oxaliplatin, capecitabine, fluorouracil-uracil, or other cytotoxic
agents) No prior systemic chemotherapy for metastatic disease No prior intra-arterial
cytotoxic chemotherapy for metastatic disease No other concurrent chemotherapy Endocrine
therapy: No concurrent anticancer hormonal therapy Radiotherapy: At least 6 months since
prior adjuvant radioimmunotherapy or radiotherapy and recovered No concurrent radiotherapy
Surgery: Recovered from prior surgery Other: At least 6 months since other prior adjuvant
therapy No other prior systemic anticancer therapy for metastatic disease No other
concurrent anticancer therapy No other concurrent experimental drugs No concurrent
participation in another clinical trial