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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
N/A
Not Enrolling
Both
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


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 CenterNew York, New York  10021
University of Colorado Cancer CenterDenver, Colorado  80262
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Sarah Cannon-Minnie Pearl Cancer CenterNashville, Tennessee  37203
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Northwestern Memorial HospitalChicago, Illinois  60611
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Harbor Hospital CenterBaltimore, Maryland  21225
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
New York Medical CollegeValhalla, New York  10595
Jackson-Madison County General HospitalJackson, Tennessee  38301
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
Sutter Cancer CenterSacramento, California  95816
Scott and White Memorial HospitalTemple, Texas  76508
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Great Falls ClinicGreat Falls, Montana  59405
California Cancer Care, Inc.Greenbrae, California  94904-2007
Emory University School of MedicineAtlanta, Georgia  30322
Providence Hospital Cancer CenterSouthfield, Michigan  48075
Nevada Cancer CenterLas Vegas, Nevada  89109
Cancer Therapy and Research CenterSan Antonio, Texas  78229
Center for Cancer And Hematologic DiseaseCherry Hill, New Jersey  08046
Mary Imogene Bassett HospitalCooperstown, New York  13326
UW Cancer Center Wausau HospitalWausau, Wisconsin  54401
HemOnCare, P.C.Brooklyn, New York  11235
Mid-Ohio Oncology/Hematology, Inc.Columbus, Ohio  43222
Cancer and Blood Institute of the DesertRancho Mirage, California  92270
Pacific Shores Medical GroupLong Beach, California  90813
Intouch ResearchHuntsville, Alabama  35801
Providence Cancer CenterMobile, Alabama  36608
Arizona Clinical Research CenterTucson, Arizona  85712
Yakima Regional Cancer Care CenterYakima, Washington  89802
Billings Oncology AssociatesBillings, Montana  59101
Midwest Hematology Oncology Consultants, Ltd.Saint Louis, Missouri  63136
Hematology Oncology AssociatesMorristown, 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 CenterFranklin, Tennessee  37067
Central Georgia Hematology Oncology, P.C.Macon, Georgia  31201
Memorial Hospital Cancer Center - ChattanoogaChattanooga, Tennessee  37404
Hope CenterTerre Haute, Indiana  47809
Oncology-Hematology Associates, P.A.Clinton, Maryland  20735
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
Family Cancer CenterCollierville, Tennessee  38017
Medical Oncology/HematologyGilroy, California  95020
Medical Oncology and Hematology, P.C.Hamden, Connecticut  06518
nTouch ResearchMelbourne, Florida  32901
Peachtree Hematology and Oncology Consultants, P.C.Atlanta, Georgia  30309
Hematology and Oncology GroupSomerset, New Jersey  08873
Summit Medical Group, P.A.Summit, New Jersey  07901
Nassau Hematology/Oncology PCLake 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 CenterLancaster, Pennsylvania  17604
Central Utah Medical ClinicProvo, Utah  84604
Rainier OncologyPuyallup, Washington  98372