Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 40 to 80 Other TRIC-TRIL-C0702 TRIL C0702, TRIC-C157, NCT00616031

Objectives

1. 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.

Entry 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

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

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
• PaO₂ ≥ 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

Expected Enrollment

Outcomes

Tumor response rate

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
Blood concentration of paclitaxel and carboplatin immediately and two hours after the administration of the anticancer drug (paclitaxel) in the first course of treatment

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.

Trial Contact Information

Trial Lead Organizations

Kyoto University Hospital

Hiroyasu Yasuda, MD, PhD, Protocol chair		Ph: 81-75-751-4770 Email: yasuda@kuhp.kyoto-u.ac.jp

Translational Research Informatics Center

Akiko Takeuchi, Research coordinator		Ph: 81-78-303-9095

Japan
Kyoto
	Kyoto
	Kyoto University Hospital
		Hiroyasu Yasuda, MD, PhD	Ph:  81-75-751-4770
			Email: yasuda@kuhp.kyoto-u.ac.jp

Registry Information
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
Trial Start Date		2008-01-04
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00616031
Date Submitted to PDQ		2008-01-25
Information Last Verified		2008-03-30

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