Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT ID: NCT00023972
Last Updated: 2012-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
INTERVENTIONAL
2001-07-31
2005-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
DX-8951f in Treating Patients With Metastatic Cancer of the Pancreas
NCT00003951
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
NCT00003810
Study of Gemcitabine Chemoradiation and TNP-470 Patients Locally Advanced, Nonmetastatic Adenocarcinoma of Pancreas
NCT00038701
Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
NCT00006467
Dasatinib and Gemcitabine Hydrochloride or Gemcitabine Hydrochloride Alone in Treating Patients With Pancreatic Cancer Previously Treated With Surgery
NCT01234935
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
exatecan mesylate
gemcitabine hydrochloride
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daiichi Sankyo
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert L. DeJager, MD, FACP
Role: STUDY_CHAIR
Daiichi Sankyo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Intouch Research
Huntsville, Alabama, United States
Providence Cancer Center
Mobile, Alabama, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
Medical Oncology/Hematology
Gilroy, California, United States
California Cancer Care, Inc.
Greenbrae, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Medical Oncology and Hematology, P.C.
Hamden, Connecticut, United States
nTouch Research
Melbourne, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Peachtree Hematology and Oncology Consultants, P.C.
Atlanta, Georgia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Central Georgia Hematology Oncology, P.C.
Macon, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Hope Center
Terre Haute, Indiana, United States
Harbor Hospital Center
Baltimore, Maryland, United States
Oncology-Hematology Associates, P.A.
Clinton, Maryland, United States
Providence Hospital Cancer Center
Southfield, Michigan, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Midwest Hematology Oncology Consultants, Ltd.
St Louis, Missouri, United States
Billings Oncology Associates
Billings, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Nevada Cancer Center
Las Vegas, Nevada, United States
Center for Cancer And Hematologic Disease
Cherry Hill, New Jersey, United States
Hematology Oncology Associates
Morristown, New Jersey, United States
Hematology and Oncology Group
Somerset, New Jersey, United States
Summit Medical Group, P.A.
Summit, New Jersey, United States
HemOnCare, P.C.
Brooklyn, New York, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, United States
Nassau Hematology/Oncology PC
Lake Success, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
New York Medical College
Valhalla, New York, United States
Buffalo Medical Group, P.C.
Williamsville, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
N.W. Carolina Oncology & Hematology, P.A.
Hickory, North Carolina, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, United States
Medical Oncology Associates of Wyoming Valley, P.C.
Kingston, Pennsylvania, United States
Lancaster Cancer Center
Lancaster, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
Memorial Hospital Cancer Center - Chattanooga
Chattanooga, Tennessee, United States
Williamson Medical Center
Franklin, Tennessee, United States
Family Cancer Center
Germantown, Tennessee, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Central Utah Medical Clinic
Provo, Utah, United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, United States
Rainier Oncology
Puyallup, Washington, United States
Yakima Regional Cancer Care Center
Yakima, Washington, United States
UW Cancer Center Wausau Hospital
Wausau, Wisconsin, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, Canada
CHUM Hopital Saint-Luc
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Veterans Affairs Medical Center - San Juan
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DAIICHI-8951A-PRT031
Identifier Type: -
Identifier Source: secondary_id
MSKCC-02011
Identifier Type: -
Identifier Source: secondary_id
CDR0000068880
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.