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
18 Years
N/A
Both
Pancreatic Cancer
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
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.
Inclusion 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
Type of Study:
Interventional
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.
Authority:
United States: Federal Government
Study ID:
CDR0000068880
NCT ID:
NCT00023972
Start Date:
July 2001
Completion Date:
April 2005
Related Keywords:
- Pancreatic Cancer
- stage III pancreatic cancer
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| 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 |
