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
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Elizabeth A. Poplin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Institute of New Jersey
Authority:
United States: Federal Government
Study ID:
CDR0000287015
NCT ID:
NCT00058149
Start Date:
March 2003
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| 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 |
