AzTrials
AzTrials

Pancreatic CancerPhase 3NCT00023972

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

A Phase 3 study testing exatecan mesylate and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Daiichi Sankyo at 74 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
exatecan mesylate and gemcitabine hydrochloride
How many people
Not given
Where
74 sitesin 3 countries
Study dates
Jul 2001to Apr 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

74 sites in 3 countries.

74 sites in 3 countries

United States66 sites

  • Peachtree Hematology and Oncology Consultants, P.C.

    Atlanta, Georgia, 30309

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Harbor Hospital Center

    Baltimore, Maryland, 21215-1290

  • Billings Oncology Associates

    Billings, Montana, 59101

  • HemOnCare, P.C.

    Brooklyn, New York, 11235

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Memorial Hospital Cancer Center - Chattanooga

    Chattanooga, Tennessee, 37404

  • Center for Cancer And Hematologic Disease

    Cherry Hill, New Jersey, 08046

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611-5933

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-1714

  • Cleveland Clinic Cancer Center

    Cleveland, Ohio, 44111

  • Oncology-Hematology Associates, P.A.

    Clinton, Maryland, 20735

  • Mid-Ohio Oncology/Hematology, Inc.

    Columbus, Ohio, 43222

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Williamson Medical Center

    Franklin, Tennessee, 37067

  • Family Cancer Center

    Germantown, Tennessee, 38138

  • Medical Oncology/Hematology

    Gilroy, California, 95020

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • California Cancer Care, Inc.

    Greenbrae, California, 94904-2007

  • Medical Oncology and Hematology, P.C.

    Hamden, Connecticut, 06518

  • N.W. Carolina Oncology & Hematology, P.A.

    Hickory, North Carolina, 28602

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813-2424

  • Intouch Research

    Huntsville, Alabama, 35801

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Medical Oncology Associates of Wyoming Valley, P.C.

    Kingston, Pennsylvania, 18704-5527

  • Nassau Hematology/Oncology PC

    Lake Success, New York, 11042

  • Lancaster Cancer Center

    Lancaster, Pennsylvania, 17604

  • Nevada Cancer Center

    Las Vegas, Nevada, 89109

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • Central Georgia Hematology Oncology, P.C.

    Macon, Georgia, 31201

  • nTouch Research

    Melbourne, Florida, 32901

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Providence Cancer Center

    Mobile, Alabama, 36608

  • Hematology Oncology Associates

    Morristown, New Jersey, 07962

  • Sarah Cannon-Minnie Pearl Cancer Center

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6307

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Lifespan: The Miriam Hospital

    Providence, Rhode Island, 02906

  • Central Utah Medical Clinic

    Provo, Utah, 84604

  • Rainier Oncology

    Puyallup, Washington, 98372

  • Cancer and Blood Institute of the Desert

    Rancho Mirage, California, 92270

  • Sutter Cancer Center

    Sacramento, California, 95816

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri, 64507

  • Intermountain Hematology/Oncology Associates, Inc.

    Salt Lake City, Utah, 84124-1363

  • Cancer Therapy and Research Center

    San Antonio, Texas, 78229-3271

  • Hematology and Oncology Group

    Somerset, New Jersey, 08873

  • Providence Hospital Cancer Center

    Southfield, Michigan, 48075

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110-0250

  • Midwest Hematology Oncology Consultants, Ltd.

    St Louis, Missouri, 63136

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11794-8174

  • Summit Medical Group, P.A.

    Summit, New Jersey, 07901

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Scott and White Memorial Hospital

    Temple, Texas, 76502

  • Hope Center

    Terre Haute, Indiana, 47802

  • Arizona Clinical Research Center

    Tucson, Arizona, 85712

  • New York Medical College

    Valhalla, New York, 10595

  • UW Cancer Center Wausau Hospital

    Wausau, Wisconsin, 54401

  • Buffalo Medical Group, P.C.

    Williamsville, New York, 14221

  • Yakima Regional Cancer Care Center

    Yakima, Washington, 98902

Other trials in United States

Canada7 sites

  • Queen Elizabeth Hospital, PEI

    Charlottetown, Prince Edward Island, C1A 8T5

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • CHUM Hopital Saint-Luc

    Montreal, Quebec, H2X 3J4

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Puerto Rico1 site

  • Veterans Affairs Medical Center - San Juan

    San Juan, 00927-5800

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Being tested
exatecan mesylate, gemcitabine hydrochloride
Keywords
stage III pancreatic cancer, stage IV pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 2001
  3. Primary completionApr 2005
  4. Study completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00023972
Sponsor's protocol ID
CDR0000068880
Other IDs
DAIICHI-8951A-PRT031, MSKCC-02011
Status last verified
May 2012
First submitted
13 Sep 2001
Last updated
16 May 2012
Results posted
No

Publications

  • Abou-Alfa GK, Letourneau R, Harker G, Modiano M, Hurwitz H, Tchekmedyian NS, Feit K, Ackerman J, De Jager RL, Eckhardt SG, O'Reilly EM. Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic cancer. J Clin Oncol. 2006 Sep 20;24(27):4441-7. doi: 10.1200/JCO.2006.07.0201.

    PubMed 16983112

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exatecan mesylate and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Daiichi Sankyo at 74 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00023972, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in