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

NCT00079287 | Completed Phase 3

• 2 other identifiers: CDR0000355138JMTO-LC00-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 24

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as vinorelbine, gemcitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying how well giving vinorelbine together with gemcitabine and docetaxel works compared to giving paclitaxel together with carboplatin in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

adenocarcinoma of the lung; large cell lung cancer; recurrent non-small cell lung cancer; squamous cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

carboplatin DRUG

docetaxel DRUG

gemcitabine hydrochloride DRUG

paclitaxel DRUG

vinorelbine tartrate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * 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 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Japan Multinational Trial Organization: lead

Study Sites (24)

Nagoya University Hospital

Aichi, 466-8560, Japan

Location

Asahikawa Medical College

Asahikawa, 078 8510, Japan

Location

National Cancer Center Hospital East

Chiba-ken, 277-8577, Japan

Location

National Hospital Organization - Ehime National Hospital

Ehime, 791-0281, Japan

Location

Aso Iizuka Hospital

Fukuoka, 820-0018, Japan

Location

National Hospital Organization - Medical Center of Kure

Hiroshima, 737-0023, Japan

Location

National Hospital Organization - Dohoku National Hospital

Hokkaido, 070-0901, Japan

Location

Fujisawa City Hospital

Kanagawa, 251-8550, Japan

Location

National Hospital Organization - Kochi Hospital

Kochi, 780-8065, Japan

Location

Kyoto-Katsura Hospital

Kyoto, 615-8256, Japan

Location

Ogaki Municipal Hospital

Ogaki-shi, 503-8502, Japan

Location

National Hospital Organization - Okayama Medical Center

Okayama, 701-1192, Japan

Location

National Hospital Organization - Okinawa Hospital

Okinawa, 901-2214, Japan

Location

Osaka Saiseikai Nakatsu Hospital

Osaka, 530-0012, Japan

Location

Osaka General Medical Center

Osaka, 558-0056, Japan

Location

Takatsuki Red Cross Hospital

Osaka, 569-1096, Japan

Location

National Hospital Organization - Osaka National Hospital

Osaka, 591-8555, Japan

Location

Saitama Cancer Center

Saitama, 362-0803, Japan

Location

Takamatsu Red Cross Hospital

Takamatsu, 760-8571, Japan

Location

Tokyo Medical and Dental University

Tokyo, 113-8519, Japan

Location

Tokyo Medical University

Tokyo, 160, Japan

Location

Tottori University Hospital

Tottori, 683-8504, Japan

Location

Toyama Medical and Pharmaceutical University Hospital

Toyama, 930-0194, Japan

Location

Koseiren Takaoka Hospital

Toyama, 933-8555, Japan

Location

Related Publications (3)

• Teramukai S, Kitano T, Kishida Y, Kawahara M, Kubota K, Komuta K, Minato K, Mio T, Fujita Y, Yonei T, Nakano K, Tsuboi M, Shibata K, Furuse K, Fukushima M. 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. 2009 Jul;45(11):1950-8. doi: 10.1016/j.ejca.2009.01.023. Epub 2009 Feb 21.

  PMID: 19231158 RESULT

• Kubota K, Kawahara M, Ogawara M, Nishiwaki Y, Komuta K, Minato K, Fujita Y, Teramukai S, Fukushima M, Furuse K; Japan Multi-National Trial Organisation. 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. 2008 Dec;9(12):1135-42. doi: 10.1016/S1470-2045(08)70261-4. Epub 2008 Nov 13.

  PMID: 19013107 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Docetaxel; Gemcitabine; Paclitaxel; Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Masaaki Kawahara, MD

  National Hospital Organization Osaka National Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 10, 2004
• Study Start: March 1, 2001
• Study Completion: November 1, 2008
• Last Updated: September 17, 2013

Record last verified: 2005-04

Locations

JP (24)