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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


Phase 2/Phase 3
40 Years
75 Years
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

progression free survival

Outcome Time Frame:

three-year

Safety Issue:

Yes

Principal Investigator

Kingo Chida, MD,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hamamatsu University School of Medicien Institution Review Board

Authority:

Japan: Institutional Review Board

Study ID:

Hamamatsu 18-66

NCT ID:

NCT00752115

Start Date:

February 2007

Completion Date:

December 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • non-small cell lung cancer
  • previously untreated
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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