3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00064064
- Lead Sponsor
- Vion Pharmaceuticals
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Sarah Cannon Cancer Center at Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands