Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002911
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
1999-11-01
Brief Title:
Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
Sponsor:
ILEX Oncology Services Incorporated
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE III MULTI-CENTER RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF MARIMASTAT IN PATIENTS WITH MINIMAL DISEASE STAGE III NON-SMALL CELL LUNG CANCER
Status:
COMPLETED
Status Verified Date:
2007-05
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:
RATIONALE Marimastat may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor
PURPOSE Randomized double-blinded phase III trial to determine the effectiveness of marimastat in treating patients who have residual stage III non-small cell lung cancer
PURPOSE Randomized double-blinded phase III trial to determine the effectiveness of marimastat in treating patients who have residual stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the effect of marimastat a matrix metalloproteinase inhibitor vs placebo on overall survival in patients with Stage III non-small cell lung cancer who have minimal residual disease following chemotherapy radiotherapy andor surgery II Assess the effect of marimastat on time to disease progression in these patients III Assess the safety and tolerability of marimastat in these patients
OUTLINE This is a randomized double-blind study Patients are randomized no less than 2 and no more than 8 weeks after the last prior treatment modality received Patients are stratified by participating institution Patients are randomly assigned to receive either oral marimastat or oral placebo twice daily Treatment begins within 5 days of minimization and continues for up to 18 months after the last patient is enrolled unless disease progression or unacceptable toxicity intervenes Patients deriving benefit at end of study may continue treatment if desired Patients are followed every 3 months
PROJECTED ACCRUAL A total of 504 patients will be entered over 30 months from approximately 60 centers
OUTLINE This is a randomized double-blind study Patients are randomized no less than 2 and no more than 8 weeks after the last prior treatment modality received Patients are stratified by participating institution Patients are randomly assigned to receive either oral marimastat or oral placebo twice daily Treatment begins within 5 days of minimization and continues for up to 18 months after the last patient is enrolled unless disease progression or unacceptable toxicity intervenes Patients deriving benefit at end of study may continue treatment if desired Patients are followed every 3 months
PROJECTED ACCRUAL A total of 504 patients will be entered over 30 months from approximately 60 centers
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-V96-1113 | None | None | None |
| ILEX-C03-IVB173 | None | None | None |
| BB-C03-IVB173 | None | None | None |