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Completed Phase 3 Interventional

Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

ClinicalTrials.gov ID: NCT00023972

Public ClinicalTrials.gov record NCT00023972. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 25, 2026, 1:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00023972
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
Not listed

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2001
Primary completion
Mar 31, 2005
Completion
Mar 31, 2005
Last update posted
May 15, 2012

2001 – 2005

United States locations

U.S. sites
66
U.S. states
27
U.S. cities
62
Facility City State ZIP Site status
Intouch Research Huntsville Alabama 35801 —
Providence Cancer Center Mobile Alabama 36608 —
Arizona Clinical Research Center Tucson Arizona 85712 —
Medical Oncology/Hematology Gilroy California 95020 —
California Cancer Care, Inc. Greenbrae California 94904-2007 —
Pacific Shores Medical Group Long Beach California 90813 —
Cancer and Blood Institute of the Desert Rancho Mirage California 92270 —
Sutter Cancer Center Sacramento California 95816 —
University of Colorado Cancer Center Denver Colorado 80010 —
Medical Oncology and Hematology, P.C. Hamden Connecticut 06518 —
nTouch Research Melbourne Florida 32901 —
Sylvester Cancer Center, University of Miami Miami Florida 33136 —
MD Anderson Cancer Center Orlando Orlando Florida 32806 —
H. Lee Moffitt Cancer Center and Research Institute Tampa Florida 33612 —
Peachtree Hematology and Oncology Consultants, P.C. Atlanta Georgia 30309 —
Emory University School of Medicine Atlanta Georgia 30322 —
Central Georgia Hematology Oncology, P.C. Macon Georgia 31201 —
Cancer Research Center of Hawaii Honolulu Hawaii 96813-2424 —
Northwestern Memorial Hospital Chicago Illinois 60611-5933 —
Lutheran General Cancer Care Center Park Ridge Illinois 60068 —
Hope Center Terre Haute Indiana 47802 —
Harbor Hospital Center Baltimore Maryland 21215-1290 —
Oncology-Hematology Associates, P.A. Clinton Maryland 20735 —
Providence Hospital Cancer Center Southfield Michigan 48075 —
Virginia Piper Cancer Institute Minneapolis Minnesota 55407 —
St. Joseph Oncology, Inc. Saint Joseph Missouri 64507 —
St. Louis University Health Sciences Center St Louis Missouri 63110-0250 —
Midwest Hematology Oncology Consultants, Ltd. St Louis Missouri 63136 —
Billings Oncology Associates Billings Montana 59101 —
Great Falls Clinic Great Falls Montana 59405 —
Nevada Cancer Center Las Vegas Nevada 89109 —
Center for Cancer And Hematologic Disease Cherry Hill New Jersey 08046 —
Hematology Oncology Associates Morristown New Jersey 07962 —
Hematology and Oncology Group Somerset New Jersey 08873 —
Summit Medical Group, P.A. Summit New Jersey 07901 —
HemOnCare, P.C. Brooklyn New York 11235 —
Mary Imogene Bassett Hospital Cooperstown New York 13326 —
Nassau Hematology/Oncology PC Lake Success New York 11042 —
Memorial Sloan-Kettering Cancer Center New York New York 10021 —
State University of New York Health Sciences Center - Stony Brook Stony Brook New York 11794-8174 —
New York Medical College Valhalla New York 10595 —
Buffalo Medical Group, P.C. Williamsville New York 14221 —
Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina 27599-7295 —
Duke Comprehensive Cancer Center Durham North Carolina 27710 —
N.W. Carolina Oncology & Hematology, P.A. Hickory North Carolina 28602 —
Ireland Cancer Center Cleveland Ohio 44106-1714 —
Cleveland Clinic Cancer Center Cleveland Ohio 44111 —
Mid-Ohio Oncology/Hematology, Inc. Columbus Ohio 43222 —
Medical Oncology Associates of Wyoming Valley, P.C. Kingston Pennsylvania 18704-5527 —
Lancaster Cancer Center Lancaster Pennsylvania 17604 —
University of Pennsylvania Cancer Center Philadelphia Pennsylvania 19104 —
Lifespan: The Miriam Hospital Providence Rhode Island 02906 —
Memorial Hospital Cancer Center - Chattanooga Chattanooga Tennessee 37404 —
Williamson Medical Center Franklin Tennessee 37067 —
Family Cancer Center Germantown Tennessee 38138 —
Jackson-Madison County General Hospital Jackson Tennessee 38301 —
Sarah Cannon-Minnie Pearl Cancer Center Nashville Tennessee 37203 —
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232-6307 —
Joe Arrington Cancer Research and Treatment Center Lubbock Texas 79410-1894 —
Cancer Therapy and Research Center San Antonio Texas 78229-3271 —
Scott and White Memorial Hospital Temple Texas 76502 —
Central Utah Medical Clinic Provo Utah 84604 —
Intermountain Hematology/Oncology Associates, Inc. Salt Lake City Utah 84124-1363 —
Rainier Oncology Puyallup Washington 98372 —
Yakima Regional Cancer Care Center Yakima Washington 98902 —
UW Cancer Center Wausau Hospital Wausau Wisconsin 54401 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00023972, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 15, 2012 · Synced Sep 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00023972 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →