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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752115
• Other study ID #: Hamamatsu 18-66
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 12, 2008
• Last updated: September 5, 2011
• Start date: February 2007
• Est. completion date: December 2010

Study information

• Verified date: April 2009
• Source: Hamamatsu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• sildenafil
50mg, day1,8 and 15 in each cycle
• placebo
1 tab, day 1,8 and 15 in each cycle.
• paclitaxel (taxol)
paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days
• carboplatin (palaplatin)
carboplatin; AUC=6 on day 1, every 28 days

Locations

Country	Name	City	State
Japan	Hamamatsu University School of Medicine	Hamamatsu

Sponsors (1)

Lead Sponsor	Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		three-year	Yes
Secondary	overall response rate		three-year	Yes