Status:
TERMINATED
Imatinib Mesylate and Gemcitabine in Treating Patients With Locally Advanced, Metastatic, or Recurrent Pancreatic Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of imatinib mesylate and gemcitabine hydrochloride in patients with locally advanced, metastatic, or recurrent pancreatic cancer. * Determi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00281996
Start Date
March 1 2005
End Date
October 1 2008
Last Update
August 26 2011
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611