RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without exatecan mesylate in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine alone to that of gemcitabine and exatecan mesylate in treating patients who have locally advanced or metastatic pancreatic cancer.

Condition	Treatment or Intervention	Phase
stage III pancreatic cancer stage IVA pancreatic cancer stage IVB pancreatic cancer	Drug: exatecan mesylate  Drug: gemcitabine  Procedure: chemotherapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare the overall survival of patients with chemotherapy-naive locally advanced or metastatic cancer of the exocrine pancreas treated with exatecan mesylate and gemcitabine versus gemcitabine alone.
• Compare the measures of clinical benefit in patients treated with these regimens.
• Compare the anti-tumor efficacy of these regimens in this patient population.
• Determine the safety profile of exatecan mesylate and gemcitabine in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (60% vs 70-80% vs 90-100%), extent of disease (locally advanced vs metastatic), and prior radiotherapy for pancreatic cancer (yes or no). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive exatecan mesylate (DX-8951f) IV over 30 minutes immediately followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive gemcitabine IV over 30 minutes once weekly for up to 7 weeks followed by one week of rest (course 1). For all subsequent courses, patients receive gemcitabine once weekly for 3 weeks followed by one week of rest. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly.

PROJECTED ACCRUAL: Approximately 340 patients (170 per treatment arm) will be accrued for this study within 18 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas
• Locally advanced (unresectable) or metastatic disease
• No islet cell tumor, lymphoma, or sarcoma of the pancreas
• No known brain metastases

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST no greater than 5 times ULN
• Albumin at least 2.8 g/dL

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No active congestive heart failure
• No uncontrolled angina
• No myocardial infarction

Other:

• No serious infection or life-threatening illness unrelated to tumor
• No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No overt psychosis or incompetency that would preclude study
• No history of a positive serology for HIV
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No prior systemic anticancer immunotherapy for pancreatic cancer
• No concurrent anticancer immunotherapy or other biologic therapy

Chemotherapy:

• No prior systemic anticancer chemotherapy for pancreatic cancer
• Prior fluorouracil as a radiosensitizer allowed
• No prior gemcitabine as a radiosensitizer
• No other concurrent anticancer chemotherapy

Endocrine therapy:

• Concurrent megestrol for appetite stimulation allowed

Radiotherapy:

• At least 28 days since prior radiotherapy and recovered
• No prior radiotherapy to more than 25% of estimated bone marrow reserve
• No concurrent anticancer radiotherapy

Surgery:

• At least 28 days since prior major surgery and recovered
• No concurrent surgery for cancer

Other:

• No prior investigational or other systemic anticancer therapy for pancreatic cancer
• No other concurrent investigational drugs

Alabama
      Providence Cancer Center, Mobile,  Alabama,  36608,  United States
      Intouch Research, Huntsville,  Alabama,  35801,  United States
Arizona
      Arizona Clinical Research Center, Tucson,  Arizona,  85712,  United States
California
      Pacific Shores Medical Group, Long Beach,  California,  90813,  United States
      Sutter Cancer Center, Sacramento,  California,  95816,  United States
      California Cancer Care, Inc., Greenbrae,  California,  94904-2007,  United States
      Cancer and Blood Institute of the Desert, Rancho Mirage,  California,  92270,  United States
      Medical Oncology/Hematology, Gilroy,  California,  95020,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
Connecticut
      Medical Oncology and Hematology, P.C., Hamden,  Connecticut,  06518,  United States
Florida
      MD Anderson Cancer Center Orlando, Orlando,  Florida,  32806,  United States
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States
      nTouch Research, Melbourne,  Florida,  32901,  United States
Georgia
      Central Georgia Hematology Oncology, P.C., Macon,  Georgia,  31201,  United States
      Peachtree Hematology and Oncology Consultants, P.C., Atlanta,  Georgia,  30309,  United States
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States
Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813-2424,  United States
Illinois
      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068,  United States
      Northwestern Memorial Hospital, Chicago,  Illinois,  60611-5933,  United States
Indiana
      Hope Center, Terre Haute,  Indiana,  47802,  United States
Maryland
      Oncology-Hematology Associates, P.A., Clinton,  Maryland,  20735,  United States
      Harbor Hospital Center, Baltimore,  Maryland,  21215-1290,  United States
Michigan
      Providence Hospital Cancer Center, Southfield,  Michigan,  48075,  United States
Minnesota
      Virginia Piper Cancer Institute, Minneapolis,  Minnesota,  55407,  United States
Missouri
      St. Joseph Oncology, Inc., Saint Joseph,  Missouri,  64507,  United States
      Midwest Hematology Oncology Consultants, Ltd., Saint Louis,  Missouri,  63136,  United States
      St. Louis University Health Sciences Center, Saint Louis,  Missouri,  63110-0250,  United States
Montana
      Great Falls Clinic, Great Falls,  Montana,  59405,  United States
      Billings Oncology Associates, Billings,  Montana,  59101,  United States
Nevada
      Nevada Cancer Center, Las Vegas,  Nevada,  89109,  United States
New Jersey
      Summit Medical Group, P.A., Summit,  New Jersey,  07901,  United States
      Hematology Oncology Associates, Morristown,  New Jersey,  07962,  United States
      Center for Cancer And Hematologic Disease, Cherry Hill,  New Jersey,  08046,  United States
      Hematology and Oncology Group, Somerset,  New Jersey,  08873,  United States
New York
      Buffalo Medical Group, P.C., Williamsville,  New York,  14221,  United States
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11794-8174,  United States
      New York Medical College, Valhalla,  New York,  10595,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      HemOnCare, P.C., Brooklyn,  New York,  11235,  United States
      Mary Imogene Bassett Hospital, Cooperstown,  New York,  13326,  United States
      Nassau Hematology/Oncology PC, Lake Success,  New York,  11042,  United States
North Carolina
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      N.W. Carolina Oncology & Hematology, P.A., Hickory,  North Carolina,  28602,  United States
Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-1714,  United States
      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44111,  United States
      Mid-Ohio Oncology/Hematology, Inc., Columbus,  Ohio,  43222,  United States
Pennsylvania
      Medical Oncology Associates of Wyoming Valley, P.C., Kingston,  Pennsylvania,  18704-5527,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States
      Lancaster Cancer Center, Lancaster,  Pennsylvania,  17604,  United States
Rhode Island
      Lifespan: The Miriam Hospital, Providence,  Rhode Island,  02906,  United States
Tennessee
      Sarah Cannon-Minnie Pearl Cancer Center, Nashville,  Tennessee,  37203,  United States
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232-6307,  United States
      Jackson-Madison County General Hospital, Jackson,  Tennessee,  38301,  United States
      Williamson Medical Center, Franklin,  Tennessee,  37067,  United States
      Memorial Hospital Cancer Center - Chattanooga, Chattanooga,  Tennessee,  37404,  United States
      Family Cancer Center, Germantown,  Tennessee,  38138,  United States
Texas
      Joe Arrington Cancer Research and Treatment Center, Lubbock,  Texas,  79410-1894,  United States
      Scott and White Memorial Hospital, Temple,  Texas,  76502,  United States
      Cancer Therapy and Research Center, San Antonio,  Texas,  78229-3271,  United States
Utah
      Central Utah Medical Clinic, Provo,  Utah,  84604,  United States
      Intermountain Hematology/Oncology Associates, Inc., Salt Lake City,  Utah,  84124-1363,  United States
Washington
      Yakima Regional Cancer Care Center, Yakima,  Washington,  98902,  United States
      Rainier Oncology, Puyallup,  Washington,  98372,  United States
Wisconsin
      UW Cancer Center Wausau Hospital, Wausau,  Wisconsin,  54401,  United States
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R2H 2A6,  Canada
Canada, Ontario
      Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury,  Ontario,  P3E 5J1,  Canada
      Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor,  Ontario,  N8W 2X3,  Canada
Canada, Prince Edward Island
      Queen Elizabeth Hospital, PEI, Charlottetown,  Prince Edward Island,  C1A 8T5,  Canada
Canada, Quebec
      CHUM Hopital Saint-Luc, Montreal,  Quebec,  H2X 3J4,  Canada
      Montreal General Hospital, Montreal,  Quebec,  H3G 1A4,  Canada
Puerto Rico
      Veterans Affairs Medical Center - San Juan, San Juan,  00927-5800,  Puerto Rico

Study chairs or principal investigators

Robert L. DeJager, MD, FACP,  Study Chair,  Daiichi Pharmaceuticals   

Study ID Numbers:  CDR0000068880; DAIICHI-8951A-PRT031; MSKCC-02011
Record last reviewed:  February 2003
Last Updated:  October 13, 2004
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00023972
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08