Status:
COMPLETED
Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 m...
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 th...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma (originating in the pancreas)
- Locally advanced or metastatic disease
- Not eligible for curative resection
- Must have measurable or evaluable disease as defined by RECIST criteria
- No CA19-9 elevation as only evidence of disease
- No known brain metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 125,000/mm³
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase \< 3 times ULN
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception
- No coexisting medical condition that would preclude study compliance
- No inability to ingest tablets
- No active illness (e.g., active or uncontrolled infection, uncontrolled cardiac disease) that would preclude study participation
- No chronic uncontrolled diarrhea and/or daily emesis
- No other cancer within the past 5 years except for surgically removed noninvasive nonmelanoma skin cancer or in situ cervical cancer
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for metastatic disease
- No prior gemcitabine
- No prior imatinib mesylate
- Prior surgical resection and adjuvant fluorouracil chemotherapy allowed provided there was an interval of \> 6 months between the last dose of adjuvant chemotherapy and recurrence of pancreatic cancer
- Prior fluorouracil as a radiosensitizing agent allowed
- At least 4 weeks since prior radiotherapy and recovered
- Must have evidence of disease outside the radiation fields OR radiologically confirmed disease progression within the radiation fields after completion of radiotherapy
- No concurrent therapeutic warfarin
- Prophylactic warfarin ≤ 1 mg daily allowed for prophylaxis of central venous catheter thrombosis
- Low molecular weight heparin or heparin allowed for anticoagulation
- No concurrent chronic systemic corticosteroids
- No other concurrent agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, or cancer surgery
- No other concurrent experimental medications
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00161213
Start Date
September 1 2005
End Date
October 1 2010
Last Update
August 14 2023
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
2
CentraState Medical Center
Freehold, New Jersey, United States, 07728
3
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
4
Jersey Shore Cancer Center at Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07754