Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas

Condition(s) targeted: Pancreatic Cancer

Intervention: cisplatin (Drug); docetaxel (Drug); gemcitabine hydrochloride (Drug); irinotecan hydrochloride (Drug); chemotherapy (Procedure)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Cancer and Leukemia Group B

Official(s) and/or principal investigator(s):
Matthew Kulke, MD, Study Chair, Affiliation: Dana-Farber Cancer Institute

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective when given alone or in combination with another chemotherapy drug in treating cancer of the pancreas. PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine given alone or in combination with other chemotherapy drugs in treating patients who have metastatic cancer of the pancreas.

Official title: A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer

Study design: Treatment, Randomized, Active Control

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan 00936-5067, Puerto Rico

Northeast Alabama Regional Medical Center, Anniston, Alabama 36207, United States

Rebecca and John Moores UCSD Cancer Center, La Jolla, California 92093-0658, United States

UCSF Comprehensive Cancer Center, San Francisco, California 94115, United States

Veterans Affairs Medical Center - San Diego, San Diego, California 92161, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California 94121, United States

CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States

Lombardi Cancer Center, Washington, District of Columbia 20007, United States

Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia 20422, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5000, United States

Broward General Medical Center, Fort Lauderdale, Florida 33316, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

Florida Hospital Cancer Institute, Orlando, Florida 32804, United States

Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center, West Palm Beach, Florida 33401, United States

Memorial Regional Hospital Comprehensive Cancer Center, Hollywood, Florida 33021, United States

Louis A. Weiss Memorial Hospital, Chicago, Illinois 60640, United States

Saint Anthony Medical Center, Rockford, Illinois 61108, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois 60612, United States

West Suburban Center for Cancer Care, River Forest, Illinois 60305, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana 46885-5099, United States

Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa 52722, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa 52242-1009, United States

Baptist Hospital East - Louisville, Louisville, Kentucky 40207, United States

Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland 21201, United States

Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland 21201, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts 01655, United States

Lakeland Medical Center - St. Joseph, Saint Joseph, Michigan 49085, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota 55417, United States

Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri 65203, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri 65201, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-7680, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada 89106, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire 03756-0002, United States

Cooper University Hospital, Camden, New Jersey 08103, United States

CCOP - North Shore University Hospital, Manhasset, New York 11030, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13217, United States

Elmhurst Hospital Center, Elmhurst, New York 11373, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

Mount Sinai Medical Center, NY, New York, New York 10029, United States

New York Weill Cornell Cancer Center at Cornell University, New York, New York 10021, United States

North Shore University Hospital, Manhasset, New York 11030, United States

Queens Cancer Center of Queens Hospital, Jamaica, New York 11432, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

State University of New York - Upstate Medical University, Syracuse, New York 13210, United States

Veterans Affairs Medical Center - Buffalo, Buffalo, New York 14215, United States

Veterans Affairs Medical Center - Syracuse, Syracuse, New York 13210, United States

Cape Fear Valley Health System, Fayetteville, North Carolina 28302-2000, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1082, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

FirstHealth Moore Regional Hospital, Pinehurst, North Carolina 28374, United States

Lenoir Memorial Hospital Cancer Center, Kinston, North Carolina 28503-1678, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States

New Hanover Regional Medical Center, Wilmington, North Carolina 28402-9025, United States

NorthEast Oncology Associates, Concord, North Carolina 28025, United States

Veterans Affairs Medical Center - Asheville, Asheville, North Carolina 28805, United States

Veterans Affairs Medical Center - Durham, Durham, North Carolina 27705, United States

Veterans Affairs Medical Center - Fargo, Fargo, North Dakota 58102, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio 43210-1240, United States

Lifespan: The Miriam Hospital, Providence, Rhode Island 02906, United States

Veterans Affairs Medical Center - Dallas, Dallas, Texas 75216, United States

Green Mountain Oncology Group, Bennington, Vermont 05201, United States

Vermont Cancer Center at University of Vermont, Burlington, Vermont 05401-3498, United States

Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont 05009, United States

Martha Jefferson Hospital, Charlottesville, Virginia 22902, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia 24014, United States

Virginia Oncology Associates - Norfolk, Norfolk, Virginia 23502, United States

St. Mary's Medical Center, Huntington, West Virginia 25701, United States

Ministry Medical Group - Northern Region, Rhinelander, Wisconsin 54501, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2001
Last updated: October 25, 2007