NCT00752115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2007

Typical duration for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 7, 2011

Status Verified

April 1, 2009

Enrollment Period

2.1 years

First QC Date

September 12, 2008

Last Update Submit

September 5, 2011

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancerpreviously untreated

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    three-year

Secondary Outcomes (1)

  • overall response rate

    three-year

Study Arms (2)

A

ACTIVE COMPARATOR

Sildenafil plus carboplatin and weekly paclitaxel

Drug: sildenafilDrug: paclitaxel (taxol)Drug: carboplatin (palaplatin)

P

PLACEBO COMPARATOR

carboplatin and weekly paclitaxel

Drug: placeboDrug: paclitaxel (taxol)Drug: carboplatin (palaplatin)

Interventions

sildenafilDRUG

50mg, day1,8 and 15 in each cycle

A
placeboDRUG

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

P
paclitaxel (taxol)DRUG

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

Also known as: taxol
AP
carboplatin (palaplatin)DRUG

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

Also known as: palaplatin
AP

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe complications or a concomitant malignancy
  • Contraindicated sildenafil, carboplatin or taxol
  • Inappropriate patients for entry to this study, judged by the physicians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Japan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Sildenafil CitratePaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Kingo Chida, MD,PhD

    Hamamatsu University School of Medicien Institution Review Board

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Respiratory Medicine

Study Record Dates

First Submitted

September 12, 2008

First Posted

September 15, 2008

Study Start

February 1, 2007

Primary Completion

March 1, 2009

Study Completion

December 1, 2010

Last Updated

September 7, 2011

Record last verified: 2009-04

Locations

JP(1)