Kidney Cancer Clinical Trial
Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
Summary
Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer. Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor
Full Description
OBJECTIVES:
I. Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma.
II. Determine the objective response rate in patients treated with this drug.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to time from diagnosis of metastatic disease to study entry (fewer than 24 months vs 24 months or more).
Patients receive oral carboxyamidotriazole (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 with stable disease are randomized to one of two treatment arms.
Arm I: Patients receive oral CAI as above.
Arm II: Patients receive a placebo.
Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression are unblinded and those on placebo begin oral CAI as above.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 335 patients will be accrued for this study within 15-25 months.
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
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There is 1 Location for this study
Chicago Illinois, 60606, United States
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