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.

Condition	Treatment or Intervention	Phase
stage II pancreatic cancer stage IVA pancreatic cancer stage III pancreatic cancer stage IVB pancreatic cancer adenocarcinoma of the pancreas	Drug: CI-994  Drug: gemcitabine	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the efficacy and safety of CI-994 given in combination with gemcitabine compared to gemcitabine alone in the treatment of patients with advanced pancreatic cancer.

PROTOCOL OUTLINE: Gemcitabine is the standard of care for pancreatic cancer and is administered by intravenous injection. Patients receive gemcitabine once a week for 3 weeks followed by 1 week of rest. Patients take the capsules (placebo or investigational chemotherapy) daily for 21 consecutive days beginning with the first gemcitabine infusion. The duration of treatment is determined by the patient's tolerance of therapy and the assessment of disease response.

PROJECTED ACCRUAL: A total of 172 patients will be enrolled in Canada, Europe, and the United States on a competitive basis.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

California
      Cedars-Sinai Comprehensive Cancer Center, Los Angeles,  California,  90048,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States
Maryland
      Sinai Hospital of Baltimore, Baltimore,  Maryland,  21225,  United States
Michigan
      William Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States
North Carolina
      Raleigh Hematology/Oncology Associates - Wake Practice, Raleigh,  North Carolina,  27609,  United States
Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
      Jewish Hospital of Cincinnati, Inc., Cincinnati,  Ohio,  45236,  United States
Tennessee
      Sarah Cannon-Minnie Pearl Cancer Center, Nashville,  Tennessee,  37203,  United States
      West Clinic, P.C., Memphis,  Tennessee,  38117,  United States
Texas
      Tyler Cancer Center, Tyler,  Texas,  75702,  United States
Virginia
      Northern Virginia Oncology Group, Fairfax,  Virginia,  22031,  United States
Canada, Manitoba
      St. Boniface General Hospital, Winnipeg,  Manitoba,  R2H 2A6,  Canada
Canada, Nova Scotia
      Nova Scotia Cancer Centre, Halifax,  Nova Scotia,  B3H 1V7,  Canada
Canada, Ontario
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada
      Ottawa Regional Cancer Center - General Division, Ottawa,  Ontario,  K1H 8L6,  Canada
Canada, Quebec
      Centre Hospitalier de l'Universite de Montreal, Montreal,  Quebec,  H2L-4M1,  Canada

Study chairs or principal investigators

Kathy M. Diener,  Study Chair,  Parke-Davis   

Study ID Numbers:  CDR0000067513; PD-994-011; ILEX-994-011
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004861
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08