A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer
OBJECTIVES:
- Compare the overall survival rate of patients with metastatic pancreatic cancer treated
with gemcitabine alone vs with cisplatin vs with docetaxel vs with irinotecan.
- Compare the time to disease progression in patients treated with these regimens.
- Compare the CA 19-9 biomarker response in patients treated with these regimens.
- Correlate the CA 19-9 biomarker response with survival in patients treated with these
regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the response in patients with measurable disease treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four
treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by
cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for at
least 2 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15.
Treatment repeats every 28 days for at least 2 courses in the absence of disease
progression or unacceptable toxicity.
- Arm III: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over
60 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in
the absence of disease progression or unacceptable toxicity.
- Arm IV: Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over
90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 240 patients (60 per arm) will be accrued for this study
within 30 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the pancreas
- Metastatic disease by CT scan
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- CTC 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase less than 2.5 times ULN if SGOT greater than 1.5 times ULN
- Alkaline phosphatase any value if SGOT less than 1.5 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
- No other currently active malignancy (completed therapy and considered to be at less
than 30% risk of relapse) except non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy except fluorouracil (5-FU)
- At least 2 weeks since prior 5-FU
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except steroids for adrenal failure, hormonal therapy
for non-disease related conditions (e.g., insulin for diabetes), or intermittent use
of dexamethasone as an antiemetic
Radiotherapy:
- At least 2 weeks since prior radiotherapy
- No concurrent palliative radiotherapy except whole-brain irradiation for CNS disease
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
4 years post treatment
Safety Issue:
No
Principal Investigator
Matthew Kulke, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000068495
NCT ID:
NCT00012220
Start Date:
January 2001
Completion Date:
April 2009
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| State University of New York - Upstate Medical University | Syracuse, New York 13210 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Mount Sinai Medical Center, NY | New York, New York 10029 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Lombardi Cancer Center | Washington, District of Columbia 20007 |
| Green Mountain Oncology Group | Rutland, Vermont 05701 |
| Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
| Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| North Shore University Hospital | Manhasset, New York 11030 |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
| Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
| Baptist Hospital East - Louisville | Louisville, Kentucky 40207 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| Veterans Affairs Medical Center - Fargo | Fargo, North Dakota 58102 |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke, Virginia 24014 |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
| Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
| Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Broward General Medical Center | Fort Lauderdale, Florida 33316 |
| Florida Hospital Cancer Institute | Orlando, Florida 32804 |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
| Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
| Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
| Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
| Memorial Regional Hospital Comprehensive Cancer Center | Hollywood, Florida 33021 |
| Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center | West Palm Beach, Florida 33401 |
| Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
| West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
| Saint Anthony Medical Center | Rockford, Illinois 61108 |
| Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
| Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |
| Lakeland Medical Center - St. Joseph | Saint Joseph, Michigan 49085 |
| Veterans Affairs Medical Center - Las Vegas | Las Vegas, Nevada 89106 |
| Cooper University Hospital | Camden, New Jersey 08103 |
| Elmhurst Hospital Center | Elmhurst, New York 11373 |
| Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
| Veterans Affairs Medical Center - Asheville | Asheville, North Carolina 28805 |
| NorthEast Oncology Associates | Concord, North Carolina 28025 |
| Cape Fear Valley Health System | Fayetteville, North Carolina 28302-2000 |
| Lenoir Memorial Hospital Cancer Center | Kinston, North Carolina 28503-1678 |
| FirstHealth Moore Regional Hospital | Pinehurst, North Carolina 28374 |
| New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
| Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
| Veterans Affairs Medical Center - Dallas | Dallas, Texas 75216 |
| Virginia Oncology Associates - Norfolk | Norfolk, Virginia 23502 |
| St. Mary's Medical Center | Huntington, West Virginia 25701 |
| Ministry Medical Group - Northern Region | Rhinelander, Wisconsin 54501 |
| Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
| Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
| New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
