Ignite Creation Date:
2024-05-05 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003011
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
1999-11-01
Brief Title:
Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Study of Marimastat in Patients With Small Cell Lung Cancer Following a Response to First Line Chemotherapy
Status:
COMPLETED
Status Verified Date:
2020-04
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 lung cancer by stopping blood flow to the tumor It is not yet known if marimastat is an effective treatment for small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of marimastat with a placebo following chemotherapy in treating patients who have small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of marimastat with a placebo following chemotherapy in treating patients who have small cell lung cancer
Detailed Description:
OBJECTIVES I Determine whether treatment with the oral matrix metalloproteinase inhibitor MMPI marimastat prolongs overall survival and time to progression in patients with small cell lung cancer who have achieved complete or partial remission after first line chemotherapy with or without radiotherapy II Determine the tolerability and toxicity of prolonged administration of marimastat in patients with small cell lung cancer III Determine the effect of prolonged administration of marimastat on the quality of life of patients with small cell lung cancer
OUTLINE This is a randomized double blind multicenter placebo controlled study Patients are stratified by stage of disease at diagnosis response to prior chemotherapyradiotherapy type of thoracic radiotherapy and cooperative group Patients are randomized into two groups Half of the patients take marimastat orally twice a day breakfast and evening meal the other half take placebo orally twice a day breakfast and evening meal Treatment continues for 2 years or until documented disease recurrence or progression and institution of further anticancer treatment occurrence of unacceptable toxicity initiation of anticoagulant treatment or development of intercurrent illness All patients are followed every 6 months until death
PROJECTED ACCRUAL The planned sample size is 360 with an equal number of patients in both arms accrued at a rate of 240 responders per year resulting in an accrual period of approximately 15 years The total duration of the study is estimated as 23 years
OUTLINE This is a randomized double blind multicenter placebo controlled study Patients are stratified by stage of disease at diagnosis response to prior chemotherapyradiotherapy type of thoracic radiotherapy and cooperative group Patients are randomized into two groups Half of the patients take marimastat orally twice a day breakfast and evening meal the other half take placebo orally twice a day breakfast and evening meal Treatment continues for 2 years or until documented disease recurrence or progression and institution of further anticancer treatment occurrence of unacceptable toxicity initiation of anticoagulant treatment or development of intercurrent illness All patients are followed every 6 months until death
PROJECTED ACCRUAL The planned sample size is 360 with an equal number of patients in both arms accrued at a rate of 240 responders per year resulting in an accrual period of approximately 15 years The total duration of the study is estimated as 23 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000065589 | REGISTRY | PDQ registration number | None |
| EORTC-08962 | OTHER | None | None |
| CAN-NCIC-BR12 | REGISTRY | None | None |