Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161213
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2005-09-08
Brief Title:
Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv or Metastatic Pancreatic Cancer
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Phase II Study of Imatinib Mesylate and Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2023-07
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 such as gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving gemcitabine together with imatinib mesylate may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works as first-line therapy in treating patients with locally advanced or metastatic pancreatic cancer
PURPOSE This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works as first-line therapy in treating patients with locally advanced or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the time to progression in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and imatinib mesylate as first-line therapy
Secondary
Assess the response rate in patients treated with this regimen
Assess the percentage of patients treated with this regimen who survive 1 year or more
Assess the toxicity of this regimen in these patients
Assess the overall survival of patients treated with this regimen
OUTLINE This is a multicenter nonrandomized open-label uncontrolled study
Patients receive gemcitabine hydrochloride IV over 120 minutes on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
Primary
Evaluate the time to progression in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and imatinib mesylate as first-line therapy
Secondary
Assess the response rate in patients treated with this regimen
Assess the percentage of patients treated with this regimen who survive 1 year or more
Assess the toxicity of this regimen in these patients
Assess the overall survival of patients treated with this regimen
OUTLINE This is a multicenter nonrandomized open-label uncontrolled study
Patients receive gemcitabine hydrochloride IV over 120 minutes on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 42 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 |
|---|---|---|---|
| CINJ-NJ1205 | OTHER | CINJ | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |
| CINJ-070501 | OTHER | None | None |
| CINJ-5324 | OTHER | None | None |