A Phase II Randomized Discontinuation Trial Of Carboxyaminoimidazole (CAI, NSC 609974) In Metastatic Renal Carcinoma
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Proportion of patients progressing on placebo to the proportion progressing on CAI
Up to 16 weeks
Cancer and Leukemia Group B
United States: Food and Drug Administration
|Cancer and Leukemia Group B||Chicago, Illinois 60606|