Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2001-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or giving drugs in different ways may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Gemcitabine; Tacedinaline

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