Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic 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: 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^3 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
Sites / Locations
- Comprehensive Cancer Institute
- CCOP - Mayo Clinic Scottsdale Oncology Program
- Medical Center of Aurora - South Campus
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- St. Joseph Hospital
- Presbyterian - St. Luke's Medical Center
- Rocky Mountain Cancer Centers - Denver Rose
- CCOP - Colorado Cancer Research Program, Incorporated
- Swedish Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- St. Mary-Corwin Regional Medical Center
- Rocky Mountain Cancer Centers - Thornton
- Winship Cancer Institute of Emory University
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Veterans Affairs Medical Center - Lakeside Chicago
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- CCOP - Central Illinois
- Decatur Memorial Hospital Cancer Care Institute
- Hinsdale Hematology Oncology Associates
- La Grange Oncology Associates
- Swedish-American Regional Cancer Center
- CCOP - Carle Cancer Center
- Indiana University Cancer Center
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- MBCCOP - LSU Health Sciences Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Cancer Center at Tufts - New England Medical Center
- Beth Israel Deaconess Medical Center
- West Michigan Cancer Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - East Orange
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- MBCCOP - University of New Mexico HSC
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- NYU Cancer Institute at New York University Medical Center
- CCOP - Merit Care Hospital
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
- CCOP - Columbus
- CCOP - Oklahoma
- CCOP - Geisinger Clinic and Medical Center
- Abramson Cancer Center at the University of Pennsylvania
- Fox Chase Cancer Center
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- CCOP - Sioux Community Cancer Consortium
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
- CCOP - Scott and White Hospital
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- University of Wisconsin Comprehensive Cancer Center
- CCOP - Marshfield Clinic Research Foundation
- Pretoria Academic Hospital