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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: sildenafil
* Drug: placebo
* Drug: paclitaxel (taxol)
* Drug: carboplatin (palaplatin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Sildenafil plus carboplatin and weekly paclitaxel | Drug: sildenafil<br>* 50mg, day1,8 and 15 in each cycle<br>Drug: paclitaxel (taxol)<br>* paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days<br>* Other names: taxol;Drug: carboplatin (palaplatin)<br>* carboplatin; AUC=6 on day 1, every 28 days<br>* Other names: palaplatin;|
| Placebo Comparator: P<br>carboplatin and weekly paclitaxel | Drug: placebo<br>* 1 tab, day 1,8 and 15 in each cycle.<br>Drug: paclitaxel (taxol)<br>* paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days<br>* Other names: taxol;Drug: carboplatin (palaplatin)<br>* carboplatin; AUC=6 on day 1, every 28 days<br>* Other names: palaplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | three-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | three-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, previously untreated