RATIONALE: Drugs used in chemotherapy such as gemcitabine and oxaliplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.

Condition	Treatment or Intervention	Phase
stage II pancreatic cancer stage III pancreatic cancer stage IVA pancreatic cancer stage IVB pancreatic cancer adenocarcinoma of the pancreas	Drug: gemcitabine  Drug: oxaliplatin  Procedure: chemotherapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare survival of patients with locally advanced or metastatic pancreatic cancer treated with prolonged infusion gemcitabine with vs without oxaliplatin vs standard infusion gemcitabine.
• Compare the toxicity of these regimens in these patients.
• Compare the objective response in patients treated with these regimens.
• Compare the patterns of failure and progression-free survival of patients treated with these regimens.
• Compare the reported frequency of deep vein thrombosis and pulmonary embolism among patients treated with these regimens.
• Compare the changes in quality of life, including improved symptom control and/or additional side effects of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2) and disease stage (locally advanced vs metastatic). Patients are randomized to 1 of 3 treatment arms.

• Arm I (standard treatment): Patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks followed by 1 week of rest for course 1 only. In all subsequent courses, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, with courses repeating every 4 weeks in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
• Arm III: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 120 minutes on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then at 8 and 16 weeks.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 789 patients (263 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 locally advanced or metastatic pancreatic adenocarcinoma or poorly differentiated carcinoma
• Ineligible for curative resection
• Measurable and/or nonmeasurable disease
• Must have evidence of disease outside prior radiation fields OR radiologically confirmed progression of disease within the radiation fields after completion of radiotherapy

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,500/mm OR
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 125,000/mm^3

Hepatic

• Bilirubin < 2.0 mg/dL
• AST < 3 times upper limit of normal (ULN)

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No uncontrolled cardiac disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Negative vaginal ultrasound for patients with an elevated beta human chorionic gonadotropin level
• Fertile patients must use effective nonhormonal contraception
• No other malignancies within the past 5 years except nonmetastatic, nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy
• No active or uncontrolled infection
• No other active illness that would preclude study participation
• No symptomatic sensory peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for metastatic disease
• No prior (including adjuvant) gemcitabine or oxaliplatin
• Prior adjuvant chemotherapy allowed provided there was more than 6 months between the last dose of adjuvant chemotherapy and recurrence of pancreatic cancer
• Prior chemotherapy as a radiosensitizing agent allowed* NOTE: *To the primary site

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy to the primary tumor site and recovered
• No prior radiotherapy to more than 25% of the functional bone marrow

Surgery

• See Disease Characteristics
• Prior surgical resection allowed

Other

• No concurrent participation in supportive care trials
• Concurrent enrollment on protocol ECOG-E1Y03 allowed

Alabama
      Comprehensive Cancer Institute, Huntsville,  Alabama,  35801,  United States
Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Colorado
      Boulder Community Hospital, Boulder,  Colorado,  80301-9019,  United States
      CCOP - Colorado Cancer Research Program, Incorporated, Denver,  Colorado,  80224,  United States
      Hope Cancer Care Center at Longmont United Hospital, Longmont,  Colorado,  80501,  United States
      Medical Center of Aurora - South Campus, Aurora,  Colorado,  80012-0000,  United States
      Penrose Cancer Center at Penrose Hospital, Colorado Springs,  Colorado,  80933,  United States
      Porter Adventist Hospital, Denver,  Colorado,  80210,  United States
      Presbyterian - St. Luke's Medical Center, Denver,  Colorado,  80218,  United States
      Rocky Mountain Cancer Centers - Denver Rose, Denver,  Colorado,  80220,  United States
      Rocky Mountain Cancer Centers - Thornton, Thornton,  Colorado,  80229,  United States
      Sky Ridge Medical Center, Lone Tree,  Colorado,  80124,  United States
      St. Joseph Hospital, Denver,  Colorado,  80218-1191,  United States
      St. Mary-Corwin Regional Medical Center, Pueblo,  Colorado,  81004,  United States
      Swedish Medical Center, Englewood,  Colorado,  80112,  United States
Georgia
      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States
      Winship Cancer Institute of Emory University, Atlanta,  Georgia,  30322,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States
      Decatur Memorial Hospital Cancer Care Institute, Decatur,  Illinois,  62526,  United States
      Hinsdale Hematology Oncology Associates, Hinsdale,  Illinois,  60521,  United States
      La Grange Oncology Associates, La Grange,  Illinois,  60525,  United States
      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611,  United States
      Swedish-American Regional Cancer Center, Rockford,  Illinois,  61104-2315,  United States
      Veterans Affairs Medical Center - Lakeside Chicago, Chicago,  Illinois,  60611-4494,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States
      Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis,  Indiana,  46202,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States
Louisiana
      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
      Cancer Center at Tufts - New England Medical Center, Boston,  Massachusetts,  02111,  United States
Michigan
      West Michigan Cancer Center, Kalamazoo,  Michigan,  49007-3731,  United States
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Jersey
      Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick,  New Jersey,  08903,  United States
      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018,  United States
New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States
New York
      Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx,  New York,  10461,  United States
      NYU Cancer Institute at New York University Medical Center, New York,  New York,  10016,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
      MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland,  Ohio,  44109,  United States
Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States
Pennsylvania
      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111-2497,  United States
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15236,  United States
      Lankenau Cancer Center at Lankenau Hospital, Wynnewood,  Pennsylvania,  19096,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
Tennessee
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-6307,  United States
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-0001,  United States
South Africa
      Pretoria Academic Hospital, Pretoria,  0001,  South Africa

Study chairs or principal investigators

Elizabeth A. Poplin, MD,  Study Chair,  Cancer Institute of New Jersey   

Study ID Numbers:  CDR0000287015; ECOG-6201; NCT00058149
Record last reviewed:  March 2005
Last Updated:  March 22, 2005
Record first received:  April 7, 2003
ClinicalTrials.gov Identifier:  NCT00058149
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08