Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003869
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
1999-11-01
Brief Title:
Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02898 | REGISTRY | None | None |
| CDR0000067033 | None | None | None |
| 97-24-51 | OTHER | None | None |
| NCCTG-97-24-51 | OTHER | None | None |
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |