Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologic or cytologic diagnosis of advanced (stage II or III) or metastatic (stage IV) adenocarcinoma of the exocrine pancreas and not considered a surgical candidate Measurable or unmeasurable disease PATIENT CHARACTERISTICS: Age: Age greater than or equal to 18 years Performance status: Karnofsky 70-100% Life expectancy: Expected survival greater than 12 weeks Hematopoietic: No inadequate bone marrow function within 2 weeks prior to randomization as evidenced by the following: Absolute neutrophil count less than 2000/mm3 Platelet count less than 100,000/mm3 Hepatic: No inadequate hepatic function within 2 weeks prior to randomization as evidenced by the following: Total bilirubin greater than 1.5 times upper limit of normal (ULN) AST or ALT greater than 3 times ULN (greater than 5 times ULN if liver metastases is documented) Renal: No inadequate renal function within 2 weeks prior to randomization as evidenced by the following: Creatinine clearance less than 50 mL/min Other: Adequate IV access to receive gemcitabine infusion Capable of swallowing intact study medication capsules Capable of giving informed consent Capable of following instructions or having a daily caregiver who assumes responsibility for administering study medication and completing medication diaries No life threatening illness (unrelated to tumor) No women of childbearing potential unless using an acceptable method of contraception, or who are pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunotherapy or biologic therapy may be allowed, but must have been completed at least 1 month prior to randomization Chemotherapy: No prior chemotherapy for advanced stage pancreatic cancer Fluorouracil (with or without leucovorin calcium or interferon) given with radiation as a radiation sensitizer may be allowed, but must have been completed at least 3 months prior to randomization Endocrine therapy: Prior hormonal therapy may be allowed, but must have been completed at least 1 month prior to randomization Radiotherapy: No radiation therapy within 4 weeks prior to first treatment Surgery: See Disease Characteristics
Sites / Locations
- Cedars-Sinai Comprehensive Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute
- Sinai Hospital of Baltimore
- William Beaumont Hospital
- Raleigh Hematology/Oncology Associates - Wake Practice
- Jewish Hospital of Cincinnati, Inc.
- Ireland Cancer Center
- West Clinic, P.C.
- Sarah Cannon-Minnie Pearl Cancer Center
- Tyler Cancer Center
- Northern Virginia Oncology Group
- St. Boniface General Hospital
- Nova Scotia Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Ottawa Regional Cancer Center - General Division
- Centre Hospitalier de l'Universite de Montreal