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3-AP and Gemcitabine in Treating Patients With Unresectable 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: NCT00064051
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: gemcitabine hydrochloride Drug: triapine Phase 2

Detailed Description:


  • Determine the objective response rate (partial and complete response) in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine.
  • Determine the progression-free interval and survival of patients treated with this regimen.
  • Determine the safety and feasibility of this regimen in these patients.

OUTLINE: This is a multicenter study.

  • Stage I: Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  • Stage II: Patients receive a higher dose of 3-AP IV continuously over 24 hours on days 1, 8, and 15. Within 1 hour of completing 3-AP administration, patients receive gemcitabine IV over 30 minutes on days 2, 9, and 16. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, every 2 months for 6 months, and then every 3 months for 18 months.

PROJECTED ACCRUAL: A total of 50-95 patients will be accrued for this study within 18-24 months.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer
Study Start Date : January 2003
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Objective response rate (partial and complete response) as assessed by RECIST criteria

Secondary Outcome Measures :
  1. Progression-free and overall survival
  2. Safety and feasibility

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.

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


  • Histologically or cytologically confirmed pancreatic cancer

    • Unresectable or metastatic disease
  • Measurable disease

    • Outside prior radiation ports OR within prior radiation port if evidence of disease progression after radiotherapy
  • No CNS metastases



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)


  • Bilirubin no greater than 2.0 mg/dL
  • AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases)
  • Chronic viral hepatitis allowed


  • Creatinine no greater than 2.0 mg/dL


  • No myocardial infarction within the past 3 months
  • No uncontrolled congestive heart failure
  • No uncontrolled coronary artery disease
  • No uncontrolled arrhythmias


  • No dyspnea at rest
  • No dependence on supplemental oxygen


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No other malignancy except any of the following:

    • Carcinoma in situ of the cervix treated with cone biopsy or resection
    • Nonmetastatic basal cell or squamous cell skin cancer
    • Any stage I malignancy curatively resected more than 5 years ago
  • No active infection
  • No known or suspected glucose-6-phosphate dehydrogenase deficiency
  • No other concurrent life threatening illness


Biologic therapy

  • Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed


  • No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy


  • More than 3 weeks since prior surgery and recovered


  • More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease
  • 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): NCT00064051

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United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, United States, 46202
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Tennessee
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States, 37203
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Vion Pharmaceuticals
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Study Chair: Mario Sznol, MD Vion Pharmaceuticals
Layout table for additonal information Identifier: NCT00064051    
Other Study ID Numbers: VION-CLI-031
CDR0000306461 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: July 9, 2003    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2008
Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
stage IV pancreatic cancer
Additional relevant MeSH terms:
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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