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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00079287
Recruitment Status : Completed
First Posted : March 10, 2004
Last Update Posted : September 17, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: vinorelbine tartrate Phase 3

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
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
Study Start Date : March 2001
Study Completion Date : November 2008

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL


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


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


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


  • 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


Biologic therapy

  • No prior biologic therapy for NSCLC


  • No prior systemic chemotherapy for NSCLC

Endocrine therapy

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


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


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


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00079287

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

Publications of Results: Identifier: NCT00079287     History of Changes
Other Study ID Numbers: CDR0000355138
First Posted: March 10, 2004    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: April 2005

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors