Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00161213
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine and Imatinib gemcitabine hydrochloride - Gemcitabine and Imatinib imatinib mesylate -
- Primary Outcome Measures
Name Time Method Progression-free Survival 4 years Progression-free survival in months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Secondary Outcome Measures
Name Time Method Overall Survival 5 years 1-year Survival Rate 5 years Percentage of subjects who survive up to 1 year
Response Rate 5 years Response rate as defined by a best response of "Stable Disease or better."
Trial Locations
- Locations (8)
Central Jersey Oncology Group
🇺🇸New Brunswick, New Jersey, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
CentraState Medical Center
🇺🇸Freehold, New Jersey, United States
Cancer Institute of New Jersey at Hamilton
🇺🇸Hamilton, New Jersey, United States
Jersey Shore Cancer Center at Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States