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

Hamamatsu University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: carboplatin (palaplatin); Drug: sildenafil; Drug: paclitaxel (taxol); Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00752115

Hamamatsu 18-66

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer
• Good performance status (ECOG 0-1)
• No previous treatment
• Adequate bone marrow, liver and renal functions
• Must be able to swallow tablets
• Provided written informed consent

Exclusion criteria

• Severe complications or a concomitant malignancy
• Contraindicated sildenafil, carboplatin or taxol
• Inappropriate patients for entry to this study, judged by the physicians

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

Sildenafil plus carboplatin and weekly paclitaxel

Treatment:

Drug: sildenafil

Drug: paclitaxel (taxol)

Drug: carboplatin (palaplatin)

P

Placebo Comparator group

Description:

carboplatin and weekly paclitaxel

Treatment:

Drug: paclitaxel (taxol)

Drug: placebo

Drug: carboplatin (palaplatin)