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About
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.
Full description
OBJECTIVES:
Primary
Secondary
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.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma (originating in the pancreas)
Not eligible for curative resection
Must have measurable or evaluable disease as defined by RECIST criteria
No known brain metastases
PATIENT CHARACTERISTICS:
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
No concurrent therapeutic warfarin
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)
Primary purpose
Allocation
Interventional model
Masking
44 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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