Paclitaxel and Carboplatin With or Without Nitroglycerin in Treating Patients With Previously Untreated Stage III or Stage IV Non-Small Cell Lung Cancer
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||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|
- Tumor response rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Adverse event and its severity [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
- Blood concentration of paclitaxel and carboplatin immediately and two hours after the administration of the anticancer drug (paclitaxel) in the first course of treatment [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- 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.
|Kyoto University Hospital||Recruiting|
|Kyoto, Japan, 606-8507|
|Contact: Hiroyasu Yasuda, MD, PhD 81-75-751-4770 firstname.lastname@example.org|
|Study Chair:||Hiroyasu Yasuda, MD, PhD||Tohoku University|
|Investigator:||Akiko Takeuchi||Translational Research Informatics Center, Kobe, Hyogo, Japan|