Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
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 renal cell carcinoma Metastatic or unresectable disease Documented disease progression, even after nephrectomy At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques At least 10 mm by spiral CT scan The following lesions are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging Cystic lesions Performance status - CTC 0-2 WBC at least 2,000/mm^3 Platelet count at least 75,000/mm^3 Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Creatinine no greater than 2.0 mg/dL Not pregnant or nursing Fertile patients must use effective contraception No baseline neuropathy or cerebellar dysfunction greater than grade 1 At least 4 weeks since prior immunotherapy No prior carboxyamidotriazole No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Concurrent epoetin alfa allowed At least 4 weeks since prior chemotherapy No concurrent chemotherapy No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes) At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy See Disease Characteristics At least 4 weeks since prior surgery
Sites / Locations
- Cancer and Leukemia Group B
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (carboxyaminoimidazole)
Arm II (carboxyamidotriazole, placebo)
Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients receive oral CAI as above.
Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients receive a placebo.