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

NCT ID: NCT00616031

Last Updated: 2013-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31

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.

Conditions

Lung Cancer

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

nitroglycerin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Kyoto University

OTHER

Sponsor Role: lead

Principal Investigators

Hiroyasu Yasuda, MD, PhD

Role: STUDY_CHAIR

Tohoku University

Akiko Takeuchi

Role:

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

Locations

Kyoto University Hospital

Kyoto, Kyoto, Japan

Site Status: RECRUITING

Countries

Japan

Facility Contacts

Hiroyasu Yasuda, MD, PhD

Role: primary

Other Identifiers

CDR0000584254

Identifier Type: REGISTRY

Identifier Source: secondary_id

TRIC-C157

Identifier Type: -

Identifier Source: secondary_id

TRIC-TRIL-C0702

Identifier Type: -

Identifier Source: org_study_id