Status:
UNKNOWN
Paclitaxel and Carboplatin With or Without Nitroglycerin in Treating Patients With Previously Untreated Stage III or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Kyoto University
Collaborating Sponsors:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Conditions:
Lung Cancer
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
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. Nitr...
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 untreate...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00616031
Start Date
January 1 2008
Last Update
August 12 2013
Active Locations (1)
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1
Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507