NCT00752115

Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

Randomized Phase II Study of Combination Chemotherapy With Sildenafil Plus Carboplatin and Weekly Paclitaxel in Patients With Previously Untreated Advanced Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hamamatsu University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A comparison of combination chemotherapy of sildenafil plus carboplatin and weekly taxol with carboplatin and weekly taxol in patients with previously untreated advanced non-small cell lung cancer. The study hypothesis is that sildenafil may improve the distribution and efficacy of cytotoxic anticancer agents.

Detailed description

Sildenafil is one of selective phosphodiesterase type 5 inhibitors. It is used to block the degradative action of phosphodiesterase type 5 on cyclic GMP in the smooth muscle cells lining the blood vessels, which leads to smooth muscle relaxation in blood vessels and increases blood flow. Because phosphodiesterase type 5 is also present in the arterial wall smooth muscle within the lungs, phosphodiesterase type 5 inhibitors is also used for the treatment of pulmonary hypertension.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	sildenafil	50mg, day1,8 and 15 in each cycle
DRUG	placebo	1 tab, day 1,8 and 15 in each cycle.
DRUG	paclitaxel (taxol)	paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days
DRUG	carboplatin (palaplatin)	carboplatin; AUC=6 on day 1, every 28 days

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-03-01
• Completion: 2010-12-01
• First posted: 2008-09-15
• Last updated: 2011-09-07

Locations

1 site across 1 country: Japan