Paclitaxel and Carboplatin With or Without Nitroglycerin in Treating Patients With Previously Untreated Stage III or Stage IV Non-Small Cell Lung Cancer

NCT00616031 | Unknown Phase 2

• 3 other identifiers: TRIC-TRIL-C0702CDR0000584254TRIC-C157
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

carboplatin DRUG

nitroglycerin DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kyoto University: lead
• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: collaborator

Study Sites (1)

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Nitroglycerin; Paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Nitro Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Hiroyasu Yasuda, MD, PhD

  Tohoku University

  STUDY CHAIR

• Akiko Takeuchi

  Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 15, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Last Updated: August 12, 2013

Record last verified: 2009-07

Locations

JP (1)