A Randomized, Open-Label, Multicenter Phase III Study of 5-FU/Leucovorin With or Without Concomitant SU5416 in Patients With Metastatic Colorectal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed or recurrent,
metastatic colorectal cancer Primary disease was adenocarcinoma of the colon or rectum
Bidimensionally measurable or evaluable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 75,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 2.2
mg/dL AST no greater than 5 times upper limit of normal Renal: Creatinine no greater than
2.0 mg/dL Creatinine clearance at least 50 mL/min Other: Not pregnant Negative pregnancy
test Fertile patients must use effective contraception No known allergy to Cremophor or
Cremophor based drug products No uncontrolled colon or small bowel disorders No other
malignancy within the past 5 years, except: Basal cell skin cancer Carcinoma in situ of
the cervix No other acute or chronic medical or psychiatric condition, or laboratory
abnormality that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy, vaccine therapy,
cytokine therapy, or biologic therapy for metastatic disease No prior angiogenesis
inhibition therapy (e.g., metalloproteinase inhibitors, thalidomide, anti-VEGF/Flk-1
monoclonal antibody therapy or other experimental drugs acting directly on the VEGF/Flk-1
signaling pathway) Prior antibody therapy, immunotherapy, gene therapy, vaccine therapy,
cytokine therapy, or radioimmunotherapy allowed in adjuvant setting only Concurrent
epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) allowed for anemia,
neutropenia, or thrombocytopenia No concurrent immunotherapy Chemotherapy: No prior
systemic chemotherapy for metastatic disease No prior intra-arterial cytotoxic
chemotherapy No more than one prior course of fluorouracil based adjuvant therapy (e.g.,
intravenous fluorouracil or capecitabine) with the last dose administered at least 6
months ago No prior SU5416 No other concurrent chemotherapy Endocrine therapy: Not
specified Radiotherapy: At least 2 weeks since prior radiotherapy Concurrent localized
palliative radiotherapy allowed unless indicative of disease progression Surgery: At least
4 weeks since prior major surgery (not including surgical placement of a venous access
device) Prior surgical resection of hepatic metastases allowed Other: No prior
investigational therapy for metastatic disease No other concurrent investigational agents