Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer
NCT ID: NCT00752115
Last Updated: 2011-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2007-02-28
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Sildenafil plus carboplatin and weekly paclitaxel
sildenafil
50mg, day1,8 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
P
carboplatin and weekly paclitaxel
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindicated sildenafil, carboplatin or taxol
* Inappropriate patients for entry to this study, judged by the physicians
40 Years
75 Years
ALL
No
Sponsors
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Hamamatsu University
OTHER
Responsible Party
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Naoki Inui
Department of Respiratory Medicine
Principal Investigators
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Kingo Chida, MD,PhD
Role: STUDY_CHAIR
Hamamatsu University School of Medicien Institution Review Board
Locations
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Hamamatsu University School of Medicine
Hamamatsu, , Japan
Countries
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Other Identifiers
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Hamamatsu 18-66
Identifier Type: -
Identifier Source: org_study_id
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