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Home > "G" Clinical Trials Conditions > Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas

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



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

For Condition: adenocarcinoma of the pancreas,stage 4B pancreatic cancer
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MatthewKulke,  Study Chair,  Dana-Farber/Harvard Cancer Center

Green Mountain Oncology Group
Bennington,  Vermont,  05201
United States
 

Lombardi Cancer Center
Washington D.C.,  District of Columbia,  20007
United States
 

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

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

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

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

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

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

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

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

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

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

Broward General Medical Center
Ft. Lauderdale,  Florida,  33316
United States
 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Elmhurst Hospital Center
Elmhurst,  New York,  11373
United States
 

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

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

Martha Jefferson Hospital
Charlottesville,  Virginia,  22902
United States
 

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

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

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

Florida Hospital Cancer Institute
Orlando,  Florida,  32804
United States
 

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

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

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

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

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

Barnes-Jewish Hospital
St. Louis,  Missouri,  63110
United States
 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

NorthEast Oncology Associates
Concord,  North Carolina,  28025
United States
 

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

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

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

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

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

Cooper University Hospital
Camden,  New Jersey,  08103
United States
 

Saint Anthony Medical Center
Rockford,  Illinois,  61108
United States
 

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

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

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

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

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


Additional Information:
Study ID Numbers:
  CDR0000068495;  CALGB-89904,CLB-89904
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012220

Other Stage 4b Pancreatic Cancer Studies:
1. UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer

2. Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer

3. CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

4. Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer

5. Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

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