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AzTrials

Lung CancerPhase 3NCT00079287

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

A Phase 3 study testing carboplatin, docetaxel and gemcitabine hydrochloride in people with Lung Cancer, run by Japan Multinational Trial Organization at 24 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, docetaxel and gemcitabine hydrochloride
How many people
Not given
Where
24 sitesJapan
Study dates
Mar 2001to Nov 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Japan24 sites

  • Nagoya University Hospital

    Aichi, 466-8560

  • Asahikawa Medical College

    Asahikawa, 078 8510

  • National Cancer Center Hospital East

    Chiba-ken, 277-8577

  • National Hospital Organization - Ehime National Hospital

    Ehime, 791-0281

  • Aso Iizuka Hospital

    Fukuoka, 820-0018

  • National Hospital Organization - Medical Center of Kure

    Hiroshima, 737-0023

  • National Hospital Organization - Dohoku National Hospital

    Hokkaido, 070-0901

  • Fujisawa City Hospital

    Kanagawa, 251-8550

  • National Hospital Organization - Kochi Hospital

    Kochi, 780-8065

  • Kyoto-Katsura Hospital

    Kyoto, 615-8256

  • Ogaki Municipal Hospital

    Ogaki-shi, 503-8502

  • National Hospital Organization - Okayama Medical Center

    Okayama, 701-1192

  • National Hospital Organization - Okinawa Hospital

    Okinawa, 901-2214

  • Osaka Saiseikai Nakatsu Hospital

    Osaka, 530-0012

  • Osaka General Medical Center

    Osaka, 558-0056

  • Takatsuki Red Cross Hospital

    Osaka, 569-1096

  • National Hospital Organization - Osaka National Hospital

    Osaka, 591-8555

  • Saitama Cancer Center

    Saitama, 362-0803

  • Takamatsu Red Cross Hospital

    Takamatsu, 760-8571

  • Tokyo Medical and Dental University

    Tokyo, 113-8519

  • Tokyo Medical University

    Tokyo, 160

  • Tottori University Hospital

    Tottori, 683-8504

  • Toyama Medical and Pharmaceutical University Hospital

    Toyama, 930-0194

  • Koseiren Takaoka Hospital

    Toyama, 933-8555

Other trials in Japan

About this study

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

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.

Conditions
Lung Cancer
Being tested
carboplatin, docetaxel, gemcitabine hydrochloride, paclitaxel, vinorelbine tartrate
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
Medical subject headings
Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2004 (estimated)
  2. Study startMar 2001
  3. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00079287
Sponsor's protocol ID
CDR0000355138
Other IDs
JMTO-LC00-03
Status last verified
Apr 2005
First submitted
8 Mar 2004
Last updated
17 Sep 2013
Results posted
No

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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, docetaxel and gemcitabine hydrochloride in people with Lung Cancer, run by Japan Multinational Trial Organization at 24 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00079287, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.

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