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3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung 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: NCT00064064
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : November 6, 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: Phase II trial to study the effectiveness of combining gemcitabine with 3-AP in treating patients who have metastatic non-small cell lung cancer.

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

Detailed Description:


  • Determine the partial and complete objective response rate in patients with metastatic non-small cell lung cancer treated with 3-AP and gemcitabine.
  • Determine the progression-free and overall survival in patients treated with this regimen.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive 3-AP IV over 4 hours followed by gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 22-50 patients will be accrued for this study.

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 Metastatic Non-Small Cell Lung Cancer
Study Start Date : January 2003
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

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.

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


  • Histologically or cytologically confirmed non-small cell lung cancer

    • Metastatic disease
  • Progressive disease after no more than 2 prior cytotoxic regimens containing at least 1 of the following drugs:

    • Cisplatin
    • Carboplatin
    • Taxane
    • Vinorelbine
  • Measurable disease
  • No CNS metastases



  • 18 and over

Performance status

  • ECOG 0-1

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
  • ALT and AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • 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 cardiac arrhythmias


  • No dyspnea at rest
  • No supplemental oxygen dependence


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No active infection
  • No other prior or concurrent malignancy except carcinoma in situ of the cervix previously treated by cone biopsy and/or resection, nonmetastatic basal cell or squamous cell skin cancer, or any stage I malignancy curatively resected more than 5 years ago
  • No other concurrent life-threatening illness


Biologic therapy

  • Prior non-cytotoxic biologic regimens allowed (e.g., vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors)


  • See Disease Characteristics
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior gemcitabine
  • No prior 3-AP

Endocrine therapy

  • Not specified


  • More than 4 weeks since prior radiotherapy and recovered


  • More than 3 weeks since prior surgery and recovered


  • More than 3 weeks since prior non-cytotoxic regimens

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): NCT00064064

United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
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
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Sponsors and Collaborators
Vion Pharmaceuticals
Study Chair: Mario Sznol, MD Vion Pharmaceuticals Identifier: NCT00064064     History of Changes
Other Study ID Numbers: CDR0000306462
First Posted: July 9, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: August 2004

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs