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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

    Hiroyasu Yasuda, MD, PhD, 81-75-751-4770, yasuda@kuhp.kyoto-u.ac.jp

    Recruiting

Other trials in Japan

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor response rate

Secondary outcomes (6)
  1. Progression-free survival

  2. Adverse event and its severity

  3. Overall survival

  4. 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

  5. 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

  6. 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.

  1. First posted15 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2011 (estimated)

Resources

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)
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

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.

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