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

May 15, 2012 updated by: Daiichi Sankyo, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068880
  • DAIICHI-8951A-PRT031
  • MSKCC-02011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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