3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00064064
First received: July 8, 2003
Last updated: November 5, 2013
Last verified: August 2004
  Purpose

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 Intervention Phase
Lung Cancer
Drug: gemcitabine hydrochloride
Drug: triapine
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2003
Study Completion Date: August 2008
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months

Hematopoietic

  • 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)

Hepatic

  • 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

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

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

Pulmonary

  • No dyspnea at rest
  • No supplemental oxygen dependence

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • 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

Radiotherapy

  • More than 4 weeks since prior radiotherapy and recovered

Surgery

  • More than 3 weeks since prior surgery and recovered

Other

  • More than 3 weeks since prior non-cytotoxic regimens
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064064

Locations
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
Netherlands
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Sponsors and Collaborators
Vion Pharmaceuticals
Investigators
Study Chair: Mario Sznol, MD Vion Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00064064     History of Changes
Other Study ID Numbers: CDR0000306462, VION-CLI-030, MDA-ID-030143
Study First Received: July 8, 2003
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 28, 2014