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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 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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00616031
Enrollment
150
Registered
2008-02-15
Start date
2008-01-31
Completion date
Unknown
Last updated
2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Brief 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. 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.

Interventions

DRUGcarboplatin
DRUGnitroglycerin
DRUGpaclitaxel

Sponsors

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
CollaboratorOTHER
Kyoto University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Tumor response rate

Secondary

MeasureTime frame
Adverse event and its severity
Overall survival
Progression-free survival
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
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026