Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-01 @ 10:59 AM
Study NCT ID:
NCT00003869
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase III Randomized, Double-Blind Study of CAI and Placebo in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized phase III trial to determine the effectiveness of carboxyamidotriazole in treating patients who have stage III or stage IV non-small cell lung cancer. Chemotherapeutic agents are modestly effective for the treatment of advanced lung cancer, with rapid tumor relapse and growth even after initial response to therapy. It is not yet known whether carboxyamidotriazole is more effective than no further treatment after standard chemotherapy for non-small cell lung cancer.
Detailed Description:
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
TERTIARY OBJECTIVES:
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.
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.
SECONDARY OBJECTIVES:
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.
TERTIARY OBJECTIVES:
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: