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

NCT00752115 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-09-07

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hamamatsu University

    lead OTHER

Principal Investigators

  • Kingo Chida, MD,PhD · Hamamatsu University School of Medicien Institution Review Board

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-03-31
Completion
2010-12-31

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00752115 on ClinicalTrials.gov