Back to resultsGemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
exatecan mesylate
gemcitabine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas Locally advanced (unresectable) or metastatic disease No islet cell tumor, lymphoma, or sarcoma of the pancreas No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 5 times ULN Albumin at least 2.8 g/dL Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction Other: No serious infection or life-threatening illness unrelated to tumor No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No overt psychosis or incompetency that would preclude study No history of a positive serology for HIV Not pregnant or nursing Negative pregnancy test Fertile patients must use contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic anticancer immunotherapy for pancreatic cancer No concurrent anticancer immunotherapy or other biologic therapy Chemotherapy: No prior systemic anticancer chemotherapy for pancreatic cancer Prior fluorouracil as a radiosensitizer allowed No prior gemcitabine as a radiosensitizer No other concurrent anticancer chemotherapy Endocrine therapy: Concurrent megestrol for appetite stimulation allowed Radiotherapy: At least 28 days since prior radiotherapy and recovered No prior radiotherapy to more than 25% of estimated bone marrow reserve No concurrent anticancer radiotherapy Surgery: At least 28 days since prior major surgery and recovered No concurrent surgery for cancer Other: No prior investigational or other systemic anticancer therapy for pancreatic cancer No other concurrent investigational drugs
Sites / Locations
- Intouch Research
- Providence Cancer Center
- Arizona Clinical Research Center
- Medical Oncology/Hematology
- California Cancer Care, Inc.
- Pacific Shores Medical Group
- Cancer and Blood Institute of the Desert
- Sutter Cancer Center
- University of Colorado Cancer Center
- Medical Oncology and Hematology, P.C.
- nTouch Research
- Sylvester Cancer Center, University of Miami
- MD Anderson Cancer Center Orlando
- H. Lee Moffitt Cancer Center and Research Institute
- Peachtree Hematology and Oncology Consultants, P.C.
- Emory University School of Medicine
- Central Georgia Hematology Oncology, P.C.
- Cancer Research Center of Hawaii
- Northwestern Memorial Hospital
- Lutheran General Cancer Care Center
- Hope Center
- Harbor Hospital Center
- Oncology-Hematology Associates, P.A.
- Providence Hospital Cancer Center
- Virginia Piper Cancer Institute
- St. Joseph Oncology, Inc.
- St. Louis University Health Sciences Center
- Midwest Hematology Oncology Consultants, Ltd.
- Billings Oncology Associates
- Great Falls Clinic
- Nevada Cancer Center
- Center for Cancer And Hematologic Disease
- Hematology Oncology Associates
- Hematology and Oncology Group
- Summit Medical Group, P.A.
- HemOnCare, P.C.
- Mary Imogene Bassett Hospital
- Nassau Hematology/Oncology PC
- Memorial Sloan-Kettering Cancer Center
- State University of New York Health Sciences Center - Stony Brook
- New York Medical College
- Buffalo Medical Group, P.C.
- Lineberger Comprehensive Cancer Center, UNC
- Duke Comprehensive Cancer Center
- N.W. Carolina Oncology & Hematology, P.A.
- Ireland Cancer Center
- Cleveland Clinic Cancer Center
- Mid-Ohio Oncology/Hematology, Inc.
- Medical Oncology Associates of Wyoming Valley, P.C.
- Lancaster Cancer Center
- University of Pennsylvania Cancer Center
- Lifespan: The Miriam Hospital
- Memorial Hospital Cancer Center - Chattanooga
- Williamson Medical Center
- Family Cancer Center
- Jackson-Madison County General Hospital
- Sarah Cannon-Minnie Pearl Cancer Center
- Vanderbilt-Ingram Cancer Center
- Joe Arrington Cancer Research and Treatment Center
- Cancer Therapy and Research Center
- Scott and White Memorial Hospital
- Central Utah Medical Clinic
- Intermountain Hematology/Oncology Associates, Inc.
- Rainier Oncology
- Yakima Regional Cancer Care Center
- UW Cancer Center Wausau Hospital
- Cross Cancer Institute
- CancerCare Manitoba
- Northeastern Ontario Regional Cancer Centre, Sudbury
- Cancer Care Ontario - Windsor Regional Cancer Centre
- Queen Elizabeth Hospital, PEI
- CHUM Hopital Saint-Luc
- Montreal General Hospital
- Veterans Affairs Medical Center - San Juan
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00023972
Brief Title
Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Official Title
A Randomized, Open-Label, Multicenter Phase III Study Comparing the Efficacy and Safety of a Combination of Intravenous DX-8951f (Exatecan Mesylate) Plus Gemcitabine to Gemcitabine Alone in Patients With Locally Advanced or Metastatic Cancer of the Exocrine Pancreas Who Have Not Received Prior Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
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 with or without exatecan mesylate in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine alone to that of gemcitabine and exatecan mesylate in treating patients who have locally advanced or metastatic pancreatic cancer.
Detailed Description
OBJECTIVES:
Compare the overall survival of patients with chemotherapy-naive locally advanced or metastatic cancer of the exocrine pancreas treated with exatecan mesylate and gemcitabine versus gemcitabine alone.
Compare the measures of clinical benefit in patients treated with these regimens.
Compare the anti-tumor efficacy of these regimens in this patient population.
Determine the safety profile of exatecan mesylate and gemcitabine in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (60% vs 70-80% vs 90-100%), extent of disease (locally advanced vs metastatic), and prior radiotherapy for pancreatic cancer (yes or no). Patients are randomized to one of two treatment arms.
Arm I: Patients receive exatecan mesylate (DX-8951f) IV over 30 minutes immediately followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive gemcitabine IV over 30 minutes once weekly for up to 7 weeks followed by one week of rest (course 1). For all subsequent courses, patients receive gemcitabine once weekly for 3 weeks followed by one week of rest. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly.
PROJECTED ACCRUAL: Approximately 340 patients (170 per treatment arm) will be accrued for this study within 18 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, stage IV pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
exatecan mesylate
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas
Locally advanced (unresectable) or metastatic disease
No islet cell tumor, lymphoma, or sarcoma of the pancreas
No known brain metastases
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
Karnofsky 60-100%
Life expectancy:
Not specified
Hematopoietic:
Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST no greater than 5 times ULN
Albumin at least 2.8 g/dL
Renal:
Creatinine no greater than 1.5 times ULN
Cardiovascular:
No active congestive heart failure
No uncontrolled angina
No myocardial infarction
Other:
No serious infection or life-threatening illness unrelated to tumor
No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No overt psychosis or incompetency that would preclude study
No history of a positive serology for HIV
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No prior systemic anticancer immunotherapy for pancreatic cancer
No concurrent anticancer immunotherapy or other biologic therapy
Chemotherapy:
No prior systemic anticancer chemotherapy for pancreatic cancer
Prior fluorouracil as a radiosensitizer allowed
No prior gemcitabine as a radiosensitizer
No other concurrent anticancer chemotherapy
Endocrine therapy:
Concurrent megestrol for appetite stimulation allowed
Radiotherapy:
At least 28 days since prior radiotherapy and recovered
No prior radiotherapy to more than 25% of estimated bone marrow reserve
No concurrent anticancer radiotherapy
Surgery:
At least 28 days since prior major surgery and recovered
No concurrent surgery for cancer
Other:
No prior investigational or other systemic anticancer therapy for pancreatic cancer
No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. DeJager, MD, FACP
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Intouch Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Providence Cancer Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Medical Oncology/Hematology
City
Gilroy
State/Province
California
ZIP/Postal Code
95020
Country
United States
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904-2007
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Cancer and Blood Institute of the Desert
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Medical Oncology and Hematology, P.C.
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
nTouch Research
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Sylvester Cancer Center, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
MD Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Peachtree Hematology and Oncology Consultants, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Central Georgia Hematology Oncology, P.C.
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813-2424
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-5933
Country
United States
Facility Name
Lutheran General Cancer Care Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Hope Center
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Harbor Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215-1290
Country
United States
Facility Name
Oncology-Hematology Associates, P.A.
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
Providence Hospital Cancer Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
St. Joseph Oncology, Inc.
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
Midwest Hematology Oncology Consultants, Ltd.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Billings Oncology Associates
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Nevada Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Center for Cancer And Hematologic Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Hematology Oncology Associates
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Hematology and Oncology Group
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
Summit Medical Group, P.A.
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
HemOnCare, P.C.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Mary Imogene Bassett Hospital
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Facility Name
Nassau Hematology/Oncology PC
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
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
State University of New York Health Sciences Center - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8174
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Buffalo Medical Group, P.C.
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
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
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
N.W. Carolina Oncology & Hematology, P.A.
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1714
Country
United States
Facility Name
Cleveland Clinic Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Mid-Ohio Oncology/Hematology, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Medical Oncology Associates of Wyoming Valley, P.C.
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704-5527
Country
United States
Facility Name
Lancaster Cancer Center
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Lifespan: The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Memorial Hospital Cancer Center - Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Williamson Medical Center
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Family Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Jackson-Madison County General Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Sarah Cannon-Minnie Pearl Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410-1894
Country
United States
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3271
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76502
Country
United States
Facility Name
Central Utah Medical Clinic
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Intermountain Hematology/Oncology Associates, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124-1363
Country
United States
Facility Name
Rainier Oncology
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Yakima Regional Cancer Care Center
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
UW Cancer Center Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Northeastern Ontario Regional Cancer Centre, Sudbury
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Cancer Care Ontario - Windsor Regional Cancer Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
Queen Elizabeth Hospital, PEI
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 8T5
Country
Canada
Facility Name
CHUM Hopital Saint-Luc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Veterans Affairs Medical Center - San Juan
City
San Juan
ZIP/Postal Code
00927-5800
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
16983112
Citation
Abou-Alfa GK, Letourneau R, Harker G, Modiano M, Hurwitz H, Tchekmedyian NS, Feit K, Ackerman J, De Jager RL, Eckhardt SG, O'Reilly EM. Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic cancer. J Clin Oncol. 2006 Sep 20;24(27):4441-7. doi: 10.1200/JCO.2006.07.0201.
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Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
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