A Phase II, Multinational and Multicenter, Randomized, Controlled Study of Paclitaxel and Carboplatin With vs Without Nitroglycerin in Patients With Untreated Advanced Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Kyoto University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Tumor response rate
- Last Updated
- 12 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Nitroglycerin may help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs.
PURPOSE: This phase II randomized trial is studying how well giving nitroglycerin together with paclitaxel and carboplatin works and compares it to giving paclitaxel and carboplatin alone in treating patients with previously untreated stage III or stage IV non-small cell lung cancer.
Detailed Description
OBJECTIVES: * To evaluate tumor response rate and safety of nitroglycerin as a potentiator of anticancer combination therapy comprising paclitaxel and carboplatin in patients with previously untreated stage IIIB or IV non-small cell lung cancer. OUTLINE: This is a multicenter, randomized, controlled study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive nitroglycerin, paclitaxel, and carboplatin. * Arm II: Patients receive paclitaxel and carboplatin. In both arms, treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Tumor response rate
Secondary Outcomes
- Progression-free survival
- Adverse event and its severity
- Overall survival
- Change in the plasma concentration of VEGF between before and after the three-day administration of nitroglycerin prior to the start of the administration of anticancer drugs in the first course of the treatment
- Change in the number of endothelial progenitor cells in blood between before and after the three-day administration of nitroglycerin prior to the start of the administration of anticancer drugs in the first course of the treatment
- Blood concentration of paclitaxel and carboplatin immediately and two hours after the administration of the anticancer drug (paclitaxel) in the first course of treatment