Imatinib Mesylate and Gemcitabine in Treating Patients With Locally Advanced, Metastatic, or Recurrent Pancreatic Cancer

• Status: Terminated
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine; Imatinib Mesylate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed pancreatic cancer

• Locally advanced, metastatic, or recurrent disease

• Measurable or evaluable disease by physical exam, plain radiographs, CT scan, or MRI

• No brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy of 12 weeks or greater

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

• No chronic liver disease (i.e., chronic active hepatitis or cirrhosis)

• Creatinine ≤ 2.0 mg/dL

• No chronic renal disease

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier-method contraception during and for ≥ 3 months after completion of study treatment

• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

• No uncontrolled diabetes

• No active uncontrolled infection

• No other severe and/or uncontrolled medical disease

• HIV negative

PRIOR CONCURRENT THERAPY:

• No prior therapy for metastatic disease

• Prior fluorouracil as a radiosensitizer for adjuvant therapy after surgery or for locally advanced disease is permitted if local disease has recurred or progressed ≥ 3 months after completion of therapy or disease is present outside the radiation field

• At least 2 weeks since prior major surgery

• No concurrent grapefruit or grapefruit juice