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
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