Imatinib Mesylate and Gemcitabine in Treating Patients With Locally Advanced, Metastatic, or Recurrent Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00281996|
Recruitment Status : Terminated (Closed to accrual to allow enrollment on another more promising trial.)
First Posted : January 25, 2006
Last Update Posted : August 26, 2011
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 I/II 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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine Drug: Imatinib mesylate||Phase 1|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Gleevec (Imatinib Mesylate, Formerly Known as STI571) and Gemcitabine for Advanced Pancreas Cancer|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
- Drug: Gemcitabine
Administered intravenously over 30 minutes on days 1 and 8 of a 21-day cycle starting at a dose of 700 mg/m2 and increasing to 1000mg/m2 by cohorts
- Drug: Imatinib mesylate
Administered orally once daily with 8 ounces of water at a starting dose of 300 mg/day and increased to 600 mg/day according to cohort.Other Name: Gleevec
- Determine maximum tolerated dose according to toxicity [ Time Frame: After 1 cycle of therapy (1 cycle = 21 days) ]
- Clinical response rate [ Time Frame: After every 2 cycles of study therapy (1 cycle = 21 days) ]
- Overall survival at 6 months [ Time Frame: After 6 months of study treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00281996
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Mary Mulcahy, MD||Robert H. Lurie Cancer Center|