Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00023972
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 16, 2012
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: exatecan mesylate Drug: gemcitabine hydrochloride Phase 3

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2001
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00023972

Show Show 74 study locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Layout table for investigator information
Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo, Inc.
Publications of Results:
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00023972    
Other Study ID Numbers: CDR0000068880
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012
Keywords provided by Daiichi Sankyo, Inc.:
stage III pancreatic cancer
stage IV pancreatic cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors