NCT00064064

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

A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Vion Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride
DRUG	triapine

Timeline

• Start date: 2003-01-01
• Completion: 2008-08-01
• First posted: 2003-07-09
• Last updated: 2013-11-06

Locations

5 sites across 2 countries: United States, Netherlands