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CompletedNCT00079287Updated Sep 17, 2013

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

A Phase 3 interventional study of carboplatin and docetaxel in Lung Cancer, sponsored by Japan Multinational Trial Organization. Completed at 24 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-17.

Sponsored by Japan Multinational Trial Organization · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

Primary

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

Secondary

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

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.

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

02

Conditions studied

  • 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
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

Browse Lung Neoplasms studies →

Lead sponsor

Japan Multinational Trial Organization is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized

Interventions

  • Drugcarboplatin
  • Drugdocetaxel
  • Druggemcitabine hydrochloride
  • Drugpaclitaxel
  • Drugvinorelbine tartrate
06

Study locations

24 sites
  • Nagoya University Hospital
    Aichi, 466-8560, Japan
  • Asahikawa Medical College
    Asahikawa, 078 8510, Japan
  • National Cancer Center Hospital East
    Chiba-ken, 277-8577, Japan
  • National Hospital Organization - Ehime National Hospital
    Ehime, 791-0281, Japan
  • Aso Iizuka Hospital
    Fukuoka, 820-0018, Japan
  • National Hospital Organization - Medical Center of Kure
    Hiroshima, 737-0023, Japan
  • National Hospital Organization - Dohoku National Hospital
    Hokkaido, 070-0901, Japan
  • Fujisawa City Hospital
    Kanagawa, 251-8550, Japan
  • National Hospital Organization - Kochi Hospital
    Kochi-shi, 780-8065, Japan
  • Kyoto-Katsura Hospital
    Kyoto, 615-8256, Japan
  • Ogaki Municipal Hospital
    Ogaki-shi, 503-8502, Japan
  • National Hospital Organization - Okayama Medical Center
    Okayama, 701-1192, Japan
  • National Hospital Organization - Okinawa Hospital
    Okinawa, 901-2214, Japan
  • Osaka General Medical Center
    Osaka-shi, 558-0056, Japan
  • Osaka Saiseikai Nakatsu Hospital
    Osaka, 530-0012, Japan
  • Takatsuki Red Cross Hospital
    Osaka, 569-1096, Japan
  • National Hospital Organization - Osaka National Hospital
    Osaka, 591-8555, Japan
  • Saitama Cancer Center
    Saitama, 362-0803, Japan
  • Takamatsu Red Cross Hospital
    Takamatsu, 760-8571, Japan
  • Tokyo Medical and Dental University
    Tokyo, 113-8519, Japan
  • Tokyo Medical University
    Tokyo, 160, Japan
  • Tottori University Hospital
    Tottori, 683-8504, Japan
  • Toyama Medical and Pharmaceutical University Hospital
    Toyama, 930-0194, Japan
  • Koseiren Takaoka Hospital
    Toyama, 933-8555, Japan
07

References and documents

Publications

  • 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. PubMed 19231158 ↗
  • 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. PubMed 19013107 ↗
  • 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.
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00079287
Lead sponsor
Japan Multinational Trial Organization
First posted
Mar 10, 2004
Start date
Mar 2001
Completion
Nov 2008
Last update
Sep 17, 2013

Study contacts

Masaaki Kawahara, MD
study chair · National Hospital Organization Osaka National Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2005. You cannot join it, but the record below documents what was studied.

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