Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281996
Status:
TERMINATED
Last Update Posted:
2011-08-26
First Post:
2006-01-24
Brief Title:
Imatinib Mesylate and Gemcitabine in Treating Patients With Locally Advanced Metastatic or Recurrent Pancreatic Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase III Study of Gleevec Imatinib Mesylate Formerly Known as STI571 and Gemcitabine for Advanced Pancreas Cancer
Status:
TERMINATED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed to accrual to allow enrollment on another more promising trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth 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 Giving imatinib mesylate together with gemcitabine may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of giving imatinib mesylate together with gemcitabine and to see how well they work in treating patients with locally advanced metastatic or recurrent pancreatic cancer
PURPOSE This phase III trial is studying the side effects and best dose of giving imatinib mesylate together with gemcitabine and to see how well they work in treating patients with locally advanced metastatic or recurrent pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of imatinib mesylate and gemcitabine hydrochloride in patients with locally advanced metastatic or recurrent pancreatic cancer
Determine the clinical response rate in patients treated with this regimen
Determine the 6-month and overall survival of patients treated with this regimen
Secondary
Determine the toxicity profile of this regimen in these patients
Correlate response with expression of platelet-derived growth factor PDGF and PDGF receptor in tumor tissue from patients treated with this regimen
OUTLINE This is a phase I dose-escalation study followed by a phase II study
Phase I Patients receive oral imatinib mesylate once daily on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-5 patients receive escalating doses of imatinib mesylate and gemcitabine hydrochloride until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 or 3 of 5 patients experience dose-limiting toxicity
NOTE The first cohort receives gemcitabine hydrochloride on days 1 8 and 15
Phase II Patients receive imatinib mesylate and gemcitabine hydrochloride at the MTD determined in phase I in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of imatinib mesylate and gemcitabine hydrochloride in patients with locally advanced metastatic or recurrent pancreatic cancer
Determine the clinical response rate in patients treated with this regimen
Determine the 6-month and overall survival of patients treated with this regimen
Secondary
Determine the toxicity profile of this regimen in these patients
Correlate response with expression of platelet-derived growth factor PDGF and PDGF receptor in tumor tissue from patients treated with this regimen
OUTLINE This is a phase I dose-escalation study followed by a phase II study
Phase I Patients receive oral imatinib mesylate once daily on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-5 patients receive escalating doses of imatinib mesylate and gemcitabine hydrochloride until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 or 3 of 5 patients experience dose-limiting toxicity
NOTE The first cohort receives gemcitabine hydrochloride on days 1 8 and 15
Phase II Patients receive imatinib mesylate and gemcitabine hydrochloride at the MTD determined in phase I in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 43 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 |
|---|---|---|---|
| NU-0948-003 | None | None | None |
| NU-02I8 | None | None | None |