Lung CancerPhase 2NCT00616031
Paclitaxel and Carboplatin With or Without Nitroglycerin in Treating Patients With Previously Untreated Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing carboplatin, nitroglycerin and paclitaxel in people with Lung Cancer, run by Kyoto University at 1 site in Japan.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Nitroglycerin may help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- carboplatin, nitroglycerin and paclitaxel
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2008to Dec 2011
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Stage IIIB or IV disease that cannot be treated by radical irradiation
- Tumor lesions must be objectively evaluated according to WHO criteria (maximum diameter is no shorter than twice the slice width and no shorter than 10 mm) by CT scan
- No brain metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- Neutrophil count > 2,000/μL
- Hemoglobin > 10.0 g/dL
- Platelet count > 100,000/μL
- Serum bilirubin < 2.0 mg/dL
- ALT and AST < 100 IU/L
- Serum creatinine < 2.0 mg/dL
- PaO_2 ≥ 70 mm Hg
- No cardiac problems, including any of the following:
- Poorly controlled hypertension
- Unstable angina
- Congestive heart failure
- Myocardial infarction within the past year
- Ventricular arrhythmia that requires treatment except single, well-controlled isolated ventricular extrasystole
- No chronic active hepatitis or cirrhosis requiring treatment except hepatitis virus carriers who do not need treatment
- No comorbidity of interstitial pneumonia and pulmonary fibrosis requiring treatment
- No other cancer requiring treatment except a malignant tumor curatively resected with no recurrence
- No severe psychiatric disorders including schizophrenia or dementia
- Cardiothoracic ratio < 60% by chest x-ray
- No history of severe drug allergy or allergy to polyoxyethylene castor oil (in some anesthetic drugs or muscle relaxants) or polysorbate 80
- Patients in whom nitroglycerin preparations are contraindicated are not eligible, including any of the following:
- Severe hypotension (e.g., systolic blood pressure ≤ 80 mm Hg)
- Angle-closure glaucoma
- History of hypersensitivity to nitrate/nitrite ester drugs
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- Pleurodesis is not considered chemotherapy
- At least 1 week since prior and no other concurrent nitric oxide donors (e.g., nitroglycerin)
- At least 1 week since prior and no concurrent calcium antagonists
- At least 1 week since prior and no concurrent drugs for erectile dysfunction that inhibit phosphodiesterase 5 (e.g., sildenafil citrate or vardenafil hydrochloride hydrate)
- More than 24 hours since prior and no concurrent administration of the following:
- Antifungal azoles, including ketoconazole, miconazole, or itraconazole
- Macrolides, including erythromycin or clarithromycin
- Cyclosporines
- Benzodiazepines, including diazepam, triazolam, or midazolam
- Vitamin A
- Steroid hormones, including ethinylestradiol
- No concurrent participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Hiroyasu Yasuda, MD, PhD, 81-75-751-4770, yasuda@kuhp.kyoto-u.ac.jp
About this study
Official title: A Phase II, Multinational and Multicenter, Randomized, Controlled Study of Paclitaxel and Carboplatin With vs Without Nitroglycerin in Patients With Untreated Advanced Non-small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Nitroglycerin may help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs.
PURPOSE: This phase II randomized trial is studying how well giving nitroglycerin together with paclitaxel and carboplatin works and compares it to giving paclitaxel and carboplatin alone in treating patients with previously untreated stage III or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- To evaluate tumor response rate and safety of nitroglycerin as a potentiator of anticancer combination therapy comprising paclitaxel and carboplatin in patients with previously untreated stage IIIB or IV non-small cell lung cancer.
OUTLINE: This is a multicenter, randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive nitroglycerin, paclitaxel, and carboplatin.
- Arm II: Patients receive paclitaxel and carboplatin. In both arms, treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, nitroglycerin, paclitaxel
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
nitroglycerinDrug
paclitaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate
Secondary outcomes (6)
Progression-free survival
Adverse event and its severity
Overall survival
Change in the plasma concentration of VEGF between before and after the three-day administration of nitroglycerin prior to the start of the administration of anticancer drugs in the first course of the treatment
Change in the number of endothelial progenitor cells in blood between before and after the three-day administration of nitroglycerin prior to the start of the administration of anticancer drugs in the first course of the treatment
Blood concentration of paclitaxel and carboplatin immediately and two hours after the administration of the anticancer drug (paclitaxel) in the first course of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Investigators
- Hiroyasu Yasuda, MD, PhD, Study chair, Tohoku UniversityAkiko Takeuchi, Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616031
- Sponsor's protocol ID
- TRIC-TRIL-C0702
- Other IDs
- CDR0000584254, TRIC-C157
- Status last verified
- Jul 2009
- First submitted
- 14 Feb 2008
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multinational and Multicenter, Randomized, Controlled Study of Paclitaxel and Carboplatin With vs Without Nitroglycerin in Patients With Untreated Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00616031
- Acronym / sponsor ID
- TRIC-TRIL-C0702
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Collaborators
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (estimated)
- First posted
- 15 Feb 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.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Nitroglycerin may help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs.
PURPOSE: This phase II randomized trial is studying how well giving nitroglycerin together with paclitaxel and carboplatin works and compares it to giving paclitaxel and carboplatin alone in treating patients with previously untreated stage III or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
- To evaluate tumor response rate and safety of nitroglycerin as a potentiator of anticancer combination therapy comprising paclitaxel and carboplatin in patients with previously untreated stage IIIB or IV non-small cell lung cancer.
OUTLINE: This is a multicenter, randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive nitroglycerin, paclitaxel, and carboplatin.
- Arm II: Patients receive paclitaxel and carboplatin. In both arms, treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| carboplatin | Drug | – |
| nitroglycerin | Drug | – |
| paclitaxel | Drug | – |
Primary outcome
Tumor response rate
6 secondary outcomes
Progression-free survival
Adverse event and its severity
Overall survival
Change in the plasma concentration of VEGF between before and after the three-day administration of nitroglycerin prior to the start of the administration of anticancer drugs in the first course of the treatment
Change in the number of endothelial progenitor cells in blood between before and after the three-day administration of nitroglycerin prior to the start of the administration of anticancer drugs in the first course of the treatment
Blood concentration of paclitaxel and carboplatin immediately and two hours after the administration of the anticancer drug (paclitaxel) in the first course of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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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.
Hiroyasu Yasuda, MD, PhD study chair
Tohoku University
Akiko Takeuchi
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin, nitroglycerin and paclitaxel in people with Lung Cancer, run by Kyoto 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?
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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate. 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 12 Aug 2013.