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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.
First Received: March 8, 2004   Last Updated: January 6, 2009   History of Changes
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

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

Resource links provided by NLM:


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

Additional Information:
Publications:
Study ID Numbers: CDR0000355138, JMTO-LC00-03
Study First Received: March 8, 2004
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00079287     History of Changes
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
Antimetabolites
Immunologic Factors
Vinblastine
Docetaxel
Respiratory Tract Diseases
Lung Neoplasms
Gemcitabine
Carboplatin
Antimitotic Agents
Antiviral Agents
Immunosuppressive Agents
Recurrence
Carcinoma
Vinorelbine
Radiation-Sensitizing Agents
Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Adenocarcinoma of Lung
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vinblastine
Docetaxel
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Vinorelbine
Radiation-Sensitizing Agents
Paclitaxel
Lung Diseases

ClinicalTrials.gov processed this record on July 02, 2009