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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00752115

Enrollment

120

Registered

2008-09-15

Start date

2007-02-28

Completion date

2010-12-31

Last updated

2011-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer, previously untreated

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.

Interventions

DRUGsildenafil

50mg, day1,8 and 15 in each cycle

DRUGplacebo

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

DRUGpaclitaxel (taxol)

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

DRUGcarboplatin (palaplatin)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
progression free survival	three-year

Secondary

Measure	Time frame
overall response rate	three-year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026