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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

Phase 3
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

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


- 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.

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



- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- 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


- Creatinine no greater than 1.5 times ULN


- No active congestive heart failure

- No uncontrolled angina

- No myocardial infarction


- 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


Biologic therapy:

- No prior systemic anticancer immunotherapy for pancreatic cancer

- No concurrent anticancer immunotherapy or other biologic therapy


- 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


- 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


- At least 28 days since prior major surgery and recovered

- No concurrent surgery for cancer


- No prior investigational or other systemic anticancer therapy for pancreatic cancer

- No other concurrent investigational drugs

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.


United States: Federal Government

Study ID:




Start Date:

July 2001

Completion Date:

April 2005

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Colorado Cancer Center Denver, Colorado  80262
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
Ireland Cancer Center Cleveland, Ohio  44106-5065
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Sylvester Cancer Center, University of Miami Miami, Florida  33136
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Sarah Cannon-Minnie Pearl Cancer Center Nashville, Tennessee  37203
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Northwestern Memorial Hospital Chicago, Illinois  60611
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Harbor Hospital Center Baltimore, Maryland  21225
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
New York Medical College Valhalla, New York  10595
Jackson-Madison County General Hospital Jackson, Tennessee  38301
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Virginia Piper Cancer Institute Minneapolis, Minnesota  55407
Sutter Cancer Center Sacramento, California  95816
Scott and White Memorial Hospital Temple, Texas  76508
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
Great Falls Clinic Great Falls, Montana  59405
California Cancer Care, Inc. Greenbrae, California  94904-2007
Emory University School of Medicine Atlanta, Georgia  30322
Providence Hospital Cancer Center Southfield, Michigan  48075
Nevada Cancer Center Las Vegas, Nevada  89109
Cancer Therapy and Research Center San Antonio, Texas  78229
Center for Cancer And Hematologic Disease Cherry Hill, New Jersey  08046
Mary Imogene Bassett Hospital Cooperstown, New York  13326
UW Cancer Center Wausau Hospital Wausau, Wisconsin  54401
HemOnCare, P.C. Brooklyn, New York  11235
Mid-Ohio Oncology/Hematology, Inc. Columbus, Ohio  43222
Cancer and Blood Institute of the Desert Rancho Mirage, California  92270
Pacific Shores Medical Group Long Beach, California  90813
Intouch Research Huntsville, Alabama  35801
Providence Cancer Center Mobile, Alabama  36608
Arizona Clinical Research Center Tucson, Arizona  85712
Yakima Regional Cancer Care Center Yakima, Washington  89802
Billings Oncology Associates Billings, Montana  59101
Midwest Hematology Oncology Consultants, Ltd. Saint Louis, Missouri  63136
Hematology Oncology Associates Morristown, New Jersey  07962
N.W. Carolina Oncology & Hematology, P.A. Hickory, North Carolina  28603
Intermountain Hematology/Oncology Associates, Inc. Salt Lake City, Utah  84124
Williamson Medical Center Franklin, Tennessee  37067
Central Georgia Hematology Oncology, P.C. Macon, Georgia  31201
Memorial Hospital Cancer Center - Chattanooga Chattanooga, Tennessee  37404
Hope Center Terre Haute, Indiana  47809
Oncology-Hematology Associates, P.A. Clinton, Maryland  20735
St. Joseph Oncology, Inc. Saint Joseph, Missouri  64506
Family Cancer Center Collierville, Tennessee  38017
Medical Oncology/Hematology Gilroy, California  95020
Medical Oncology and Hematology, P.C. Hamden, Connecticut  06518
nTouch Research Melbourne, Florida  32901
Peachtree Hematology and Oncology Consultants, P.C. Atlanta, Georgia  30309
Hematology and Oncology Group Somerset, New Jersey  08873
Summit Medical Group, P.A. Summit, New Jersey  07901
Nassau Hematology/Oncology PC Lake Success, New York  11042
Buffalo Medical Group, P.C. Williamsville, New York  14221
Medical Oncology Associates of Wyoming Valley, P.C. Kingston, Pennsylvania  18704-5527
Lancaster Cancer Center Lancaster, Pennsylvania  17604
Central Utah Medical Clinic Provo, Utah  84604
Rainier Oncology Puyallup, Washington  98372