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

September 5, 2011 updated by: Naoki Inui, Hamamatsu University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hamamatsu, Japan
        • Hamamatsu University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Sildenafil plus carboplatin and weekly paclitaxel
Drug: sildenafil
50mg, day1,8 and 15 in each cycle
Drug: paclitaxel (taxol)
paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days
Other Names:
  • taxol
Drug: carboplatin (palaplatin)
carboplatin; AUC=6 on day 1, every 28 days
Other Names:
  • palaplatin
PLACEBO_COMPARATOR: P
carboplatin and weekly paclitaxel
Drug: paclitaxel (taxol)
paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days
Other Names:
  • taxol
Drug: carboplatin (palaplatin)
carboplatin; AUC=6 on day 1, every 28 days
Other Names:
  • palaplatin
Drug: placebo
1 tab, day 1,8 and 15 in each cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: three-year
three-year

Secondary Outcome Measures

Outcome Measure
Time Frame
overall response rate
Time Frame: three-year
three-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamamatsu University

Investigators

  • Study Chair: Kingo Chida, MD,PhD, Hamamatsu University School of Medicien Institution Review Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

September 12, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (ESTIMATE)

September 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 5, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamamatsu 18-66

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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