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NCT Number: NCT00752115

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hamamatsu University School of Medicine

Hamamatsu, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

50mg, day1,8 and 15 in each cycle

Placebo

Drug

1 tab, day 1,8 and 15 in each cycle.

Paclitaxel (Taxol)

Drug

paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days

Other names: taxol

carboplatin (palaplatin)

Drug

carboplatin; AUC=6 on day 1, every 28 days

Other names: palaplatin

Primary outcomes

  1. progression free survival

    Time frame: three-year

Secondary outcomes

  1. overall response rate

    Time frame: three-year

Sponsors and collaborators

Lead sponsor

Hamamatsu University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Sep 15, 2008
Registry last updated
Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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