- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00079287
Vinorelbine, Gemcitabine, and Docetaxel Compared With Paclitaxel and Carboplatin in Treating Patients With Advanced Non-Small Cell Lung Cancer
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Aichi, Japan, 466-8560
- Nagoya University Hospital
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Asahikawa, Japan, 078 8510
- Asahikawa Medical College
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Chiba-ken, Japan, 277-8577
- National Cancer Center Hospital East
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Ehime, Japan, 791-0281
- National Hospital Organization - Ehime National Hospital
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Fukuoka, Japan, 820-0018
- Aso Iizuka Hospital
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Hiroshima, Japan, 737-0023
- National Hospital Organization - Medical Center of Kure
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Hokkaido, Japan, 070-0901
- National Hospital Organization - Dohoku National Hospital
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Kanagawa, Japan, 251-8550
- Fujisawa City Hospital
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Kochi-shi, Japan, 780-8065
- National Hospital Organization - Kochi Hospital
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Kyoto, Japan, 615-8256
- Kyoto-Katsura Hospital
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Ogaki-shi, Japan, 503-8502
- Ogaki Municipal Hospital
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Okayama, Japan, 701-1192
- National Hospital Organization - Okayama Medical Center
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Okinawa, Japan, 901-2214
- National Hospital Organization - Okinawa Hospital
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Osaka, Japan, 530-0012
- Osaka Saiseikai Nakatsu Hospital
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Osaka, Japan, 591-8555
- National Hospital Organization - Osaka National Hospital
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Osaka, Japan, 569-1096
- Takatsuki Red Cross Hospital
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Osaka-shi, Japan, 558-0056
- Osaka General Medical Center
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Saitama, Japan, 362-0803
- Saitama Cancer Center
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Takamatsu, Japan, 760-8571
- Takamatsu Red Cross Hospital
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Tokyo, Japan, 113-8519
- Tokyo Medical and Dental University
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Tokyo, Japan, 160
- Tokyo Medical University
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Tottori, Japan, 683-8504
- Tottori University Hospital
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Toyama, Japan, 933-8555
- Koseiren Takaoka Hospital
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Toyama, Japan, 930-0194
- Toyama Medical and Pharmaceutical University Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Masaaki Kawahara, MD, National Hospital Organization Osaka National Hospital
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Lungentumoren
- Karzinom, nicht-kleinzellige Lunge
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Antineoplastische Mittel, Phytogen
- Gemcitabin
- Docetaxel
- Carboplatin
- Paclitaxel
- Vinorelbin
Andere Studien-ID-Nummern
- CDR0000355138
- JMTO-LC00-03
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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