Phase III Randomized, Double-Blind Study of CAI and Placebo in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
I. To determine whether oral administration of the carboxyaminoimidazole (CAI) is more
effective than placebo in prolonging the overall survival in patients with non-small cell
lung cancer stage III or stage IV non-small cell lung cancer who have been stable or had
tumor regression following chemotherapy.
I. To evaluate the safety and tolerability of oral CAI following chemotherapy. II. To
determine whether CAI prolongs time-to-disease progression relative to a placebo.
III. To evaluate whether a substantive effect in quality of life (QOL) can be detected
between the CAI and placebo groups using the FACT-L and the UNISCALE.
IV. To document the response rate to CAI in patients with measurable or evaluable disease.
I. To evaluate genotypes at GSH-related loci as predictors of overall survival.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to timing of first-line therapy (prior to registration vs after registration),
disease stage (IIIA vs IIIB vs IV), therapy components (chemotherapy and thoracic
radiotherapy vs chemotherapy only), ECOG performance status (0 vs 1 vs 2) and participating
center. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral carboxyamidotriazole daily.
ARM II: Patients receive oral placebo daily.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then monthly during study.
Patients are followed every 3 months for 5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Overall Survival (OS)
OS was defined as the time from randomization to death of any cause. Participants who did not die or were lost to follow-up were censored at the time of last evaluation/follow-up date. Patients were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
up to 5 years
North Central Cancer Treatment Group
United States: Food and Drug Administration
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