Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004861
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2000-03-07
Brief Title:
Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic 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 in the Treatment of Patients With Advanced Pancreatic 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 Combining more than one drug or giving drugs in different ways may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced pancreatic cancer
PURPOSE Randomized phase II trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced pancreatic cancer
Detailed Description:
OBJECTIVES I Determine the efficacy and safety of CI-994 given in combination with gemcitabine compared to gemcitabine alone in the treatment of patients with advanced pancreatic cancer
OUTLINE Gemcitabine is the standard of care for pancreatic cancer and is administered by intravenous injection Patients receive gemcitabine once a week for 3 weeks followed by 1 week of rest Patients take the capsules placebo or investigational chemotherapy daily for 21 consecutive days beginning with the first gemcitabine infusion The duration of treatment is determined by the patients tolerance of therapy and the assessment of disease response
PROJECTED ACCRUAL A total of 172 patients will be enrolled in Canada Europe and the United States on a competitive basis
OUTLINE Gemcitabine is the standard of care for pancreatic cancer and is administered by intravenous injection Patients receive gemcitabine once a week for 3 weeks followed by 1 week of rest Patients take the capsules placebo or investigational chemotherapy daily for 21 consecutive days beginning with the first gemcitabine infusion The duration of treatment is determined by the patients tolerance of therapy and the assessment of disease response
PROJECTED ACCRUAL A total of 172 patients will be enrolled in Canada Europe and the United States on a competitive basis
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-994-011 | None | None | None |
| CDR0000067513 | None | None | None |