Non-small Cell Lung CancerPhase 2/3NCT00752115
Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer
A Phase 2/3 study testing sildenafil, paclitaxel (taxol) and carboplatin (palaplatin) in people with Non-small Cell Lung Cancer, run by Hamamatsu University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- sildenafil, paclitaxel (taxol) and carboplatin (palaplatin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2007to Dec 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe complications or a concomitant malignancy
- Contraindicated sildenafil, carboplatin or taxol
- Inappropriate patients for entry to this study, judged by the physicians
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- sildenafil, placebo, paclitaxel (taxol), carboplatin (palaplatin)
- Keywords
- non-small cell lung cancer, previously untreated
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
50mg, day1,8 and 15 in each cycle
placeboDrug
1 tab, day 1,8 and 15 in each cycle.
paclitaxel (taxol)Drug
Also called taxol
paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days
carboplatin (palaplatin)Drug
Also called palaplatin
carboplatin; AUC=6 on day 1, every 28 days
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Sildenafil plus carboplatin and weekly paclitaxel Receives: Drug: sildenafil; Drug: paclitaxel (taxol); Drug: carboplatin (palaplatin) |
| P | Placebo comparator | carboplatin and weekly paclitaxel Receives: Drug: placebo; Drug: paclitaxel (taxol); Drug: carboplatin (palaplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: three-year
Secondary outcomes (1)
overall response rate
Measured: three-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startFeb 2007
- Primary completionMar 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamamatsu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naoki Inui, Hamamatsu University
- Investigators
- Kingo Chida, MD,PhD, Study chair, Hamamatsu University School of Medicien Institution Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752115
- Sponsor's protocol ID
- Hamamatsu 18-66
- Status last verified
- Apr 2009
- First submitted
- 12 Sep 2008
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00752115
- Acronym / sponsor ID
- Hamamatsu 18-66
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, previously untreated
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hamamatsu UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: sildenafil, Drug: paclitaxel (taxol), Drug: carboplatin (palaplatin)Sildenafil plus carboplatin and weekly paclitaxel |
| P | Placebo comparator | Drug: placebo, Drug: paclitaxel (taxol), Drug: carboplatin (palaplatin)carboplatin and weekly paclitaxel |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Severe complications or a concomitant malignancy
- Contraindicated sildenafil, carboplatin or taxol
- Inappropriate patients for entry to this study, judged by the physicians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sildenafil50mg, day1,8 and 15 in each cycle | Drug | A |
| placebo1 tab, day 1,8 and 15 in each cycle. | Drug | P |
| paclitaxel (taxol)Also: taxolpaclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days | Drug | A, P |
| carboplatin (palaplatin)Also: palaplatincarboplatin; AUC=6 on day 1, every 28 days | Drug | A, P |
Primary outcome
progression free survival
Time frame: three-year
1 secondary outcome
overall response rate
Time frame: three-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kingo Chida, MD,PhD study chair
Hamamatsu University School of Medicien Institution Review Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing sildenafil, paclitaxel (taxol) and carboplatin (palaplatin) in people with Non-small Cell Lung Cancer, run by Hamamatsu University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: three-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011.