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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cisplatin
docetaxel
gemcitabine hydrochloride
irinotecan hydrochloride
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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

Sites / Locations

  • Northeast Alabama Regional Medical Center
  • Rebecca and John Moores UCSD Cancer Center
  • Veterans Affairs Medical Center - San Diego
  • UCSF Comprehensive Cancer Center
  • Veterans Affairs Medical Center - San Francisco
  • CCOP - Christiana Care Health Services
  • Lombardi Cancer Center
  • Walter Reed Army Medical Center
  • Veterans Affairs Medical Center - Washington, DC
  • Broward General Medical Center
  • Memorial Regional Hospital Comprehensive Cancer Center
  • CCOP - Mount Sinai Medical Center
  • Florida Hospital Cancer Institute
  • Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • West Suburban Center for Cancer Care
  • Saint Anthony Medical Center
  • Fort Wayne Medical Oncology and Hematology, Incorporated
  • CCOP - Northern Indiana CR Consortium
  • Hematology Oncology Associates of the Quad Cities
  • Holden Comprehensive Cancer Center at University of Iowa
  • Baptist Hospital East - Louisville
  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  • Veterans Affairs Medical Center - Baltimore
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • University of Massachusetts Memorial Medical Center - University Campus
  • Lakeland Medical Center - St. Joseph
  • Veterans Affairs Medical Center - Minneapolis
  • University of Minnesota Cancer Center
  • Veterans Affairs Medical Center - Columbia (Truman Memorial)
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • Barnes-Jewish Hospital
  • University of Nebraska Medical Center
  • CCOP - Southern Nevada Cancer Research Foundation
  • Veterans Affairs Medical Center - Las Vegas
  • Norris Cotton Cancer Center
  • Cooper University Hospital
  • Veterans Affairs Medical Center - Buffalo
  • Roswell Park Cancer Institute
  • Elmhurst Hospital Center
  • Queens Cancer Center of Queens Hospital
  • CCOP - North Shore University Hospital
  • North Shore University Hospital
  • Memorial Sloan-Kettering Cancer Center
  • New York Weill Cornell Cancer Center at Cornell University
  • Mount Sinai Medical Center, NY
  • State University of New York - Upstate Medical University
  • Veterans Affairs Medical Center - Syracuse
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • Veterans Affairs Medical Center - Asheville
  • Lineberger Comprehensive Cancer Center, UNC
  • NorthEast Oncology Associates
  • Veterans Affairs Medical Center - Durham
  • Duke Comprehensive Cancer Center
  • Cape Fear Valley Health System
  • Lenoir Memorial Hospital Cancer Center
  • FirstHealth Moore Regional Hospital
  • New Hanover Regional Medical Center
  • CCOP - Southeast Cancer Control Consortium
  • Comprehensive Cancer Center at Wake Forest University
  • Veterans Affairs Medical Center - Fargo
  • Arthur G. James Cancer Hospital - Ohio State University
  • Lifespan: The Miriam Hospital
  • Veterans Affairs Medical Center - Dallas
  • Green Mountain Oncology Group
  • Vermont Cancer Center at University of Vermont
  • Veterans Affairs Medical Center - White River Junction
  • Martha Jefferson Hospital
  • Virginia Oncology Associates - Norfolk
  • MBCCOP - Massey Cancer Center
  • Oncology and Hematology Associates of Southwest Virginia, Inc.
  • St. Mary's Medical Center
  • Ministry Medical Group - Northern Region
  • University of Puerto Rico School of Medicine Medical Sciences Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Gemcitabine

Gemcitabine + cisplastin

Gemcitabine + docetaxel

Gemcitabine + Irinotecan

Arm Description

Standard treatment

Addition of cisplastin to gemcitabine

Addition of docetaxel to gemcitabine

Addition of irinotecan to gemcitabine

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Time to disease progression
Toxicity

Full Information

First Posted
March 3, 2001
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00012220
Brief Title
Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With 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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
259 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine
Arm Type
Active Comparator
Arm Description
Standard treatment
Arm Title
Gemcitabine + cisplastin
Arm Type
Experimental
Arm Description
Addition of cisplastin to gemcitabine
Arm Title
Gemcitabine + docetaxel
Arm Type
Experimental
Arm Description
Addition of docetaxel to gemcitabine
Arm Title
Gemcitabine + Irinotecan
Arm Type
Experimental
Arm Description
Addition of irinotecan to gemcitabine
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
50 mg/sq m IV infusion over 30 min on Days 1 & 15 of ea cycle
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
40 mg/sq m IV infusion over 60 min on Days 1 & 8 of ea treatment cycle
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
Gemcitabine only arm: 1500 mg/sq m in 250 mL NS IV infusion over 150 min Days 1, 8, & 15 of ea cycle cisplastin arm: 1000 mg/sq m 250 mL NS IV infusion over 30 min Days 1, 8, 15 of ea cycle docetaxel and + irinotecan arms: 1000 mg/sq m in 250 mL NS IV infusion over 30 min Days 1 & 8 of ea cycle
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Description
100 mg/q m in 500 mL D5W or D5NS IV infusion over 90 min Days 1 & 8 of ea cycle
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
4 years post treatment
Secondary Outcome Measure Information:
Title
Time to disease progression
Time Frame
treatment up to 4 years post treatment
Title
Toxicity
Time Frame
treatment and up to 4 years post treatment

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
19858396
Citation
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 Nov 20;27(33):5506-12. doi: 10.1200/JCO.2009.22.1309. Epub 2009 Oct 26.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

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

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