Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: gemcitabine hydrochloride; imatinib mesylate
Intervention MeSH terms: Gemcitabine; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent pancreatic cancer; stage IV pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas; stage II pancreatic cancer

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.
    

Eligibility criteria:

        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)