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

Alternate Title

Vinorelbine, Gemcitabine, and Docetaxel Compared With Paclitaxel and Carboplatin in Treating Patients With Advanced Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	JMTO-LC00-03 NCT00079287

Objectives

Primary

1. Compare the therapeutic effect of vinorelbine, gemcitabine, and docetaxel vs paclitaxel and carboplatin in patients with advanced non-small cell lung cancer.
2. Compare the overall survival of patients treated with these regimens.

Secondary

1. Compare the response rate in patients treated with these regimens.
2. Compare the toxicity of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting criteria for 1 of the following:
  • Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) disease
  • Newly diagnosed stage IV disease
  • Recurrent disease after prior surgery and/or radiotherapy
• The following cellular subtypes are allowed:
  • Adenocarcinoma
  • Large cell carcinoma
  • Squamous cell carcinoma
  • Unspecified carcinoma
• Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical examination, or bone scintigraphy
  • Pleural effusions, ascites, and laboratory parameters are not allowed as the only evidence of disease
  • Disease must be present outside area of prior surgical resection
  • Disease must be present outside area of prior radiotherapy OR new lesion documented
• No known brain metastases by CT scan or MRI within the past 6 weeks
• No pleural or pericardial effusions requiring treatment

Prior/Concurrent Therapy:

Biologic therapy

• No prior biologic therapy for NSCLC

Chemotherapy

• No prior systemic chemotherapy for NSCLC

Endocrine therapy

• No prior or concurrent steroid-type hormonal therapy (e.g., ethinyl estradiol)

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered

Surgery

• See Disease Characteristics
• At least 2 weeks since prior thoracic or other major surgery and recovered

Other

• No prior or concurrent azole antifungal therapy (e.g., ketoconazole, miconazole, or itraconazole)
• No prior or concurrent macrolides (e.g., erythromycin or clarithromycin)
• No prior or concurrent cyclosporine, terfenadine, benzodiazepines (e.g., diazepam, triazolam, or midazolam), or retinoids
• No prior or concurrent calcium antagonists (e.g., diltiazem, nifedipine, or verapamil)

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• SGOT or SGPT ≤ 2 times ULN
• Alkaline phosphatase ≤ 2 times ULN

Renal

• Creatinine ≤ ULN
• Creatinine clearance ≥ 50 mL/min

Cardiovascular

• No uncontrolled hypertension
• No unstable angina
• No congestive heart failure
• No myocardial infarction within the past year
• No ventricular arrhythmia requiring medical intervention

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No prior allergic drug reaction attributed to Cremophor or polysorbate 80
• No disorder associated with lung cancer with life-threatening consequences
• No motor or sensory neuropathy ≥ grade 2
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• No uncontrolled diabetes

Expected Enrollment

A total of 400 patients (200 per treatment arm) will be accrued for this study within 2 years.

Outline

This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive vinorelbine IV and gemcitabine IV on days 1 and 8. Treatment repeats every 21 days for 3 courses. Patients then receive docetaxel IV on day 1. Treatment repeats every 21 days for 3 courses.
• Arm II: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for 6 courses.

Patients are followed for 1 year.

Teramukai S, Kitano T, Kishida Y, et al.: Pretreatment neutrophil count as an independent prognostic factor in advanced non-small-cell lung cancer: an analysis of Japan Multinational Trial Organisation LC00-03. Eur J Cancer 45 (11): 1950-8, 2009.[PUBMED Abstract]

Kubota K, Kawahara M, Ogawara M, et al.: Vinorelbine plus gemcitabine followed by docetaxel versus carboplatin plus paclitaxel in patients with advanced non-small-cell lung cancer: a randomised, open-label, phase III study. Lancet Oncol 9 (12): 1135-42, 2008.[PUBMED Abstract]

Teramukai S, Nishimura T, Nakagawa M, et al.: Predictors and impacts of second-line chemotherapy on survival after progression in patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 25 (Suppl 18): A-7675, 2007.

Trial Contact Information

Trial Lead Organizations

Japan and Multinational Clinical Trial Organization

Masaaki Kawahara, MD, Protocol chair		Ph: 81-72-252-3021 Email: kawaharam@kch.hosp.go.jp

Registry Information
Official Title		Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients with Advanced Non-Small Cell Lung Cancer
Trial Start Date		2001-03-29
Registered in ClinicalTrials.gov		NCT00079287
Date Submitted to PDQ		2004-01-29
Information Last Verified		2005-04-14

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