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

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00012220

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Cisplatin Gemcitabine Irinotecan U 101440E Docetaxel Gemcitabine hydrochloride Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	January 2001
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012220

Hide Study Locations

Locations

United States, Alabama
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States, 20422
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, United States, 33401
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, United States, 33021
United States, Illinois
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Kentucky
Baptist Hospital East - Louisville
Louisville, Kentucky, United States, 40207
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
North Shore University Hospital
Manhasset, New York, United States, 11030
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
Cape Fear Valley Health System
Fayetteville, North Carolina, United States, 28302-2000
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States, 28503-1678
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402-9025
NorthEast Oncology Associates
Concord, North Carolina, United States, 28025
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States, 28805
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
United States, North Dakota
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States, 58102
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Rhode Island
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States, 75216
United States, Vermont
Green Mountain Oncology Group
Bennington, Vermont, United States, 05201
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05401-3498
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22902
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States, 23502
United States, West Virginia
St. Mary's Medical Center
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, United States, 54501
Puerto Rico
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Matthew Kulke, MD

Dana-Farber Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Kulke MH, Tempero MA, Niedzwiecki D, Hollis DR, Kindler HL, Cusnir M, Enzinger PC, Gorsch SM, Goldberg RM, Mayer RJ. Randomized Phase II Study of Gemcitabine Administered at a Fixed Dose Rate or in Combination With Cisplatin, Docetaxel, or Irinotecan in Patients With Metastatic Pancreatic Cancer: CALGB 89904. J Clin Oncol. 2009 Oct 26; [Epub ahead of print]

Kulke MH, Niedzwiecki D, Tempero MA, et al.: A randomized phase II study of gemcitabine/cisplatin, gemcitabine fixed dose rate infusion, gemcitabine/docetaxel, or gemcitabine/irinotecan in patients with metastatic pancreatic cancer (CALGB 89904). [Abstract] J Clin Oncol 22 (Suppl 14): A-4011, 316s, 2004.

Study ID Numbers:	CDR0000068495, CALGB-89904
Study First Received:	March 3, 2001
Last Updated:	November 3, 2009
ClinicalTrials.gov Identifier:	NCT00012220 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Irinotecan
Physiological Effects of Drugs
Docetaxel
Neoplasms by Site
Cisplatin
Therapeutic Uses
Gemcitabine

Endocrine Gland Neoplasms
Digestive System Neoplasms
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Camptothecin
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 25, 2009