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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
50mg, day1,8 and 15 in each cycle
1 tab, day 1,8 and 15 in each cycle.
paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days
Hamamatsu University School of Medicine
Hamamatsu, Japan
progression free survival
Time frame: three-year
overall response rate
Time frame: three-year
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carboplatin; AUC=6 on day 1, every 28 days