Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005093
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2000-04-06
Brief Title:
Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Study of CI-994 Capsules Plus Gemcitabine Infusion Versus Placebo Capsules Plus Gemcitabine Infusion as Second-Line Treatment of Patients With Advanced Nonsmall Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether gemcitabine plus CI-994 is more effective than gemcitabine alone for non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the efficacy and safety of gemcitabine with or without CI-994 in patients with advanced non-small cell lung cancer
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to performance status and are randomized to one of two treatment arms Arm I Patients receive CI-994 orally on days 1-21 and gemcitabine IV over 30 minutes on days 1 8 and 15 Arm II Patients receive placebo capsules orally on days 1-21 and gemcitabine as in arm I Treatment repeats every 28 days as long as medically appropriate absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 176 patients will be accrued for this study
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to performance status and are randomized to one of two treatment arms Arm I Patients receive CI-994 orally on days 1-21 and gemcitabine IV over 30 minutes on days 1 8 and 15 Arm II Patients receive placebo capsules orally on days 1-21 and gemcitabine as in arm I Treatment repeats every 28 days as long as medically appropriate absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 176 patients will be accrued for this study
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 |
|---|---|---|---|
| ILEX-994-013 | None | None | None |
| CDR0000067735 | None | None | None |