Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced Colorectal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic or locally recurrent adenocarcinoma of the colon
or rectum

- Progressive disease as defined by new or progressive radiologic lesions

- Measurable disease at least 1 dimension as at least 20 mm with conventional
techniques or at least 10 mm with spiral CT scan

- Lesions seen on colonoscopic examination or barium studies, bone metastases, CNS
lesions, CEA levels and ascites are not considered measurable

- Lesion accessible for biopsy which is not within prior radiation port

- Known history of CNS metastasis allowed if patients have had treatment, are
neurologically stable, and do not require oral or intravenous steroids or
anticonvulsants, provided brain scan (CT or MRI) shows absence of active or residual
disease

- If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan
required

PATIENT CHARACTERISTICS:

- Age: 18 and over

- Performance status: WHO 0-2

- Life expectancy: At least 12 weeks

- WBC at least 3,000/mm3

- Platelet count at least 75,000/mm3

- Bilirubin no greater than 1.5 mg/dL

- Transaminases no greater than 2.5 times upper limit of normal

- Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min

- No uncompensated coronary artery disease

- No history of myocardial infarction or severe/unstable angina within past 6 months

- No severe peripheral vascular disease associated with diabetes mellitus

- No deep venous or arterial thrombosis within past 3 months

- No pulmonary embolism within past 3 months

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other significant uncontrolled underlying medical or psychiatric illness

- No serious active infections

- No concurrent second malignancy except for nonmelanoma skin cancer or carcinoma in
situ of the cervix unless completed therapy and considered to be at less than 30%
risk of relapse

- No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel

PRIOR CONCURRENT THERAPY:

- No more than 2 prior chemotherapy regimens for metastatic disease

- At least 4 weeks since prior chemotherapy

- No concurrent chemotherapy

- No other concurrent investigational antineoplastic drugs

- No prior radiotherapy to only site of measurable disease

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

- At least 30 days since other prior investigational drugs