A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma
- Compare survival of patients with locally advanced or metastatic pancreatic cancer
treated with prolonged infusion gemcitabine with vs without oxaliplatin vs standard
- 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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Elizabeth A. Poplin, MD
Cancer Institute of New Jersey
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Southern Nevada Cancer Research Foundation||Las Vegas, Nevada 89106|
|Veterans Affairs Medical Center - Atlanta (Decatur)||Decatur, Georgia 30033|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|Veterans Affairs Medical Center - Indianapolis (Roudebush)||Indianapolis, Indiana 46202|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|Veterans Affairs Medical Center - East Orange||East Orange, New Jersey 07018-1095|
|Boulder Community Hospital||Boulder, Colorado 80301-9019|
|Penrose Cancer Center at Penrose Hospital||Colorado Springs, Colorado 80933|
|Porter Adventist Hospital||Denver, Colorado 80210|
|Presbyterian - St. Luke's Medical Center||Denver, Colorado 80218|
|St. Joseph Hospital||Denver, Colorado 80218|
|Swedish Medical Center||Englewood, Colorado 80110|
|Sky Ridge Medical Center||Lone Tree, Colorado 80124|
|Hope Cancer Care Center at Longmont United Hospital||Longmont, Colorado 80502|
|Hinsdale Hematology Oncology Associates||Hinsdale, Illinois 60521|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - MainLine Health||Wynnewood, Pennsylvania 19096|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Cancer Center at Tufts - New England Medical Center||Boston, Massachusetts 02111|
|MBCCOP - University of New Mexico HSC||Albuquerque, New Mexico 87131|
|MetroHealth's Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44106|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|Abramson Cancer Center at the University of Pennsylvania||Philadelphia, Pennsylvania 19104|
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center||Nashville, Tennessee 37232-2516|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|Veterans Affairs Medical Center - Lakeside Chicago||Chicago, Illinois 60611|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|Veterans Affairs Medical Center - Wichita||Wichita, Kansas 67218|
|MBCCOP - LSU Health Sciences Center||New Orleans, Louisiana 70112|
|CCOP - Oklahoma||Tulsa, Oklahoma 74136|
|CCOP - Colorado Cancer Research Program, Incorporated||Denver, Colorado 80224|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15236|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine||Bronx, New York 10461|
|NYU Cancer Institute at New York University Medical Center||New York, New York 10016|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|Comprehensive Cancer Institute||Huntsville, Alabama 35801|
|Swedish-American Regional Cancer Center||Rockford, Illinois 61104-2315|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|St. Mary-Corwin Regional Medical Center||Pueblo, Colorado 81004|
|Lankenau Cancer Center at Lankenau Hospital||Wynnewood, Pennsylvania 19096|
|CCOP - Mayo Clinic Scottsdale Oncology Program||Scottsdale, Arizona 85259|
|Medical Center of Aurora - South Campus||Aurora, Colorado 80012-0000|
|Rocky Mountain Cancer Centers - Denver Rose||Denver, Colorado 80220|
|Rocky Mountain Cancer Centers - Thornton||Thornton, Colorado 80229|
|La Grange Oncology Associates||La Grange, Illinois 60525|