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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
sildenafil
placebo
paclitaxel (taxol)
carboplatin (palaplatin)
Sponsored by
Hamamatsu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring non-small cell lung cancer, previously untreated

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hamamatsu University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

P

Arm Description

Sildenafil plus carboplatin and weekly paclitaxel

carboplatin and weekly paclitaxel

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

overall response rate

Full Information

First Posted
September 12, 2008
Last Updated
September 5, 2011
Sponsor
Hamamatsu University
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1. Study Identification

Unique Protocol Identification Number
NCT00752115
Brief Title
Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamamatsu University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
non-small cell lung cancer, previously untreated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Sildenafil plus carboplatin and weekly paclitaxel
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
carboplatin and weekly paclitaxel
Intervention Type
Drug
Intervention Name(s)
sildenafil
Intervention Description
50mg, day1,8 and 15 in each cycle
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 tab, day 1,8 and 15 in each cycle.
Intervention Type
Drug
Intervention Name(s)
paclitaxel (taxol)
Other Intervention Name(s)
taxol
Intervention Description
paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days
Intervention Type
Drug
Intervention Name(s)
carboplatin (palaplatin)
Other Intervention Name(s)
palaplatin
Intervention Description
carboplatin; AUC=6 on day 1, every 28 days
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
three-year
Secondary Outcome Measure Information:
Title
overall response rate
Time Frame
three-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kingo Chida, MD,PhD
Organizational Affiliation
Hamamatsu University School of Medicien Institution Review Board
Official's Role
Study Chair
Facility Information:
Facility Name
Hamamatsu University School of Medicine
City
Hamamatsu
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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