SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal 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 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
Sites / Locations
- University of Illinois at Chicago
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- Cancer Care Specialists of Central Illinois, S.C.
- Evanston Northwestern Health Care
- Division of Hematology/Oncology
- Oncology/Hematology Associates of Central Illinois, P.C.
- Central Illinois Hematology Oncology Center
- Fort Wayne Medical Oncology and Hematology, Inc.
- Michiana Hematology/Oncology P.C.
Arms of the Study
Arm 1
Experimental
Arm I
Patient receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.