SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer
About this trial
This is an interventional treatment trial for Recurrent Renal Cell Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed metastatic renal cell carcinoma Prior removal of primary tumors Bidimensionally measurable disease Bone-only disease is not considered measurable Progressive disease following no more than 2 prior biologic therapy (e.g.,interleukin-2, interferon alfa, vaccine, or dendritic cell therapy) orfluorouracil-containing (single-agent or in combination therapy) regimens No known history of CNS metastasis unless all of the following are true: Previously treated Neurologically stable No requirement for IV steroids or anticonvulsants No requirement for oral steroids and no evidence of active or residual CNS disease on CT scan or MRI Negative brain scan (CT scan or MRI) required if neurologic signs or symptoms suggestive of CNS metastasis present Performance status - Zubrod 0-2 At least 12 weeks Absolute neutrophil count at least 1,500/mm^3 Platelet count greater than 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL SGPT no greater than 2.5 times upper limit of normal PT and PTT normal Fibrinogen normal D-Dimer assay normal Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min See Surgery No active congestive heart failure No uncontrolled angina No myocardial infarction or severe/unstable angina within the past 6 months No uncontrolled hypertension No uncompensated coronary artery disease on electrocardiogram or physical examination No severe peripheral vascular disease No deep vein or arterial thrombosis within the past 3 months No pulmonary embolism within the past 3 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No overt psychosis, mental disability, or incompetence No diabetes mellitus No other prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No hypersensitivity or allergic reaction to paclitaxel See Disease Characteristics No other concurrent anti-cancer biologic therapy See Disease Characteristics No concurrent anti-cancer chemotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No sole indicator lesion within the previously irradiated port No concurrent anti-cancer radiotherapy See Disease Characteristics At least 4 weeks since prior major surgery and recovered At least 1 year since prior bypass surgery for atherosclerotic coronary artery disease No concurrent surgery for cancer No other investigational drugs (e.g., analgesics or antiemetics) for at least 28 days prior to and after study
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (semaxanib)
Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with CR receive an additional 6 months of therapy after achieving CR.