Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00023972

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 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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: exatecan mesylate Drug: gemcitabine hydrochloride	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Exatecan Exatecan mesylate

U.S. FDA Resources

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

Study Start Date:

July 2001

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023972

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Locations

United States, Alabama
Providence Cancer Center
Mobile, Alabama, United States, 36608
Intouch Research
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, California
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Sutter Cancer Center
Sacramento, California, United States, 95816
California Cancer Care, Inc.
Greenbrae, California, United States, 94904-2007
Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States, 92270
Medical Oncology/Hematology
Gilroy, California, United States, 95020
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Connecticut
Medical Oncology and Hematology, P.C.
Hamden, Connecticut, United States, 06518
United States, Florida
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
nTouch Research
Melbourne, Florida, United States, 32901
United States, Georgia
Central Georgia Hematology Oncology, P.C.
Macon, Georgia, United States, 31201
Peachtree Hematology and Oncology Consultants, P.C.
Atlanta, Georgia, United States, 30309
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813-2424
United States, Illinois
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611-5933
United States, Indiana
Hope Center
Terre Haute, Indiana, United States, 47802
United States, Maryland
Oncology-Hematology Associates, P.A.
Clinton, Maryland, United States, 20735
Harbor Hospital Center
Baltimore, Maryland, United States, 21215-1290
United States, Michigan
Providence Hospital Cancer Center
Southfield, Michigan, United States, 48075
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, Missouri
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, United States, 64507
Midwest Hematology Oncology Consultants, Ltd.
Saint Louis, Missouri, United States, 63136
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
United States, Montana
Great Falls Clinic
Great Falls, Montana, United States, 59405
Billings Oncology Associates
Billings, Montana, United States, 59101
United States, Nevada
Nevada Cancer Center
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Summit Medical Group, P.A.
Summit, New Jersey, United States, 07901
Hematology Oncology Associates
Morristown, New Jersey, United States, 07962
Center for Cancer And Hematologic Disease
Cherry Hill, New Jersey, United States, 08046
Hematology and Oncology Group
Somerset, New Jersey, United States, 08873
United States, New York
Buffalo Medical Group, P.C.
Williamsville, New York, United States, 14221
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11794-8174
New York Medical College
Valhalla, New York, United States, 10595
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
HemOnCare, P.C.
Brooklyn, New York, United States, 11235
Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
Nassau Hematology/Oncology PC
Lake Success, New York, United States, 11042
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
N.W. Carolina Oncology & Hematology, P.A.
Hickory, North Carolina, United States, 28602
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-1714
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44111
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, United States, 43222
United States, Pennsylvania
Medical Oncology Associates of Wyoming Valley, P.C.
Kingston, Pennsylvania, United States, 18704-5527
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Lancaster Cancer Center
Lancaster, Pennsylvania, United States, 17604
United States, Rhode Island
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
Williamson Medical Center
Franklin, Tennessee, United States, 37067
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6307
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States, 37203
Memorial Hospital Cancer Center - Chattanooga
Chattanooga, Tennessee, United States, 37404
Family Cancer Center
Germantown, Tennessee, United States, 38138
United States, Texas
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
Scott and White Memorial Hospital
Temple, Texas, United States, 76502
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229-3271
United States, Utah
Central Utah Medical Clinic
Provo, Utah, United States, 84604
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, United States, 84124-1363
United States, Washington
Yakima Regional Cancer Care Center
Yakima, Washington, United States, 98902
Rainier Oncology
Puyallup, Washington, United States, 98372
United States, Wisconsin
UW Cancer Center Wausau Hospital
Wausau, Wisconsin, United States, 54401
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Prince Edward Island
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
CHUM Hopital Saint-Luc
Montreal, Quebec, Canada, H2X 3J4
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan, Puerto Rico, 00927-5800

Sponsors and Collaborators

Daiichi Sankyo Inc.

Investigators

Study Chair:

Robert L. DeJager, MD, FACP

Daiichi Sankyo Inc.

More Information

Additional Information:

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

Publications:

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.

Study ID Numbers:	CDR0000068880, DAIICHI-8951A-PRT031, MSKCC-02011
Study First Received:	September 13, 2001
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00023972 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
DX 8951
Neoplasms by Site
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 27, 2009