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

This study is ongoing, but not recruiting participants.

Sponsored by: Japan Multinational Trial Organization
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00079287
  Purpose

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 Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: docetaxel
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Drug: vinorelbine ditartrate
Phase III

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Carboplatin    Docetaxel    Vinorelbine    Vinorelbine tartrate    Gemcitabine hydrochloride    Gemcitabine    Paclitaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 2001

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079287

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

Sponsors and Collaborators
Japan Multinational Trial Organization

Investigators
Study Chair:     Masaaki Kawahara, MD     National Hospital Organization - Osaka National Hospital    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000355138, JMTO-LC00-03
First Received:   March 8, 2004
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00079287
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Vinblastine
Carboplatin
Recurrence
Carcinoma
Docetaxel
Adenocarcinoma of lung
Vinorelbine
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 18, 2008




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