Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
Randomized Study With New Combination Chemotherapies in Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use 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 advanced non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES: I. Compare the overall survival between paclitaxel/cisplatin (arm I), gemcitabine/cisplatin (arm II), and paclitaxel/gemcitabine (arm III) in patients with advanced non-small cell lung cancer. II. Determine the response rate, duration of response, progression-free survival, toxicity, and quality of life of these patients randomized in these three treatment arms.
OUTLINE: This is randomized, multicenter study. Patients are stratified according to performance status (0-1 vs 2) and stage of disease (locally advanced vs metastatic). Patients are randomized to receive paclitaxel IV over 3 hours on day 1 followed by cisplatin IV on day 1 every 3 weeks (arm I), gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin IV on day 1 every 3 weeks (arm II), or paclitaxel IV over 3 hours on day 1 followed by gemcitabine IV over 30-60 minutes on days 1 and 8 every 3 weeks (arm III). Patients receive at least 2 courses of treatment. In the absence of unacceptable toxicity and disease progression, patients may receive up to 6 courses of treatment. Quality of life is assessed before, during, and at the end of treatment, then every 6 weeks until disease progression, and then every 3 months until death. Patients are followed every 6 weeks until disease progression, then every 3 months until death.
PROJECTED ACCRUAL: A total of 450 patients (150 patients per arm) will be accrued into this study over 36 months.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Antwerp, Belgien, 2020
- Algemeen Ziekenhuis Middelheim
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Cairo, Egypten
- National Cancer Institute of Egypt
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Vandoeuvre-Les-Nancy, Frankrike, 54511
- CHRU de Nancy - Hôpitaux de Brabois
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Athens, Grekland, GR-11527
- Hippokration General Hospital of Athens
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Biella, Italien, 13900
- Ospedale Degli Infermi
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's-Gravenhage (Den Haag, The Hague), Nederländerna, 2545 CH
- Leyenburg Ziekenhuis
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's-Hertogenbosch, Nederländerna, 5211 NL
- Groot Ziekengasthuis 's-Hertogenbosch
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Amsterdam, Nederländerna, 1105 AZ
- Academisch Medisch Centrum
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Amsterdam, Nederländerna, 1091 HA
- Onze Lieve Vrouwe Gasthuis
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Amsterdam, Nederländerna, 1117 MB
- Academisch Ziekenhuis der Vrije Universiteit
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Apeldoorn, Nederländerna, 7334 DZ
- Gelre Ziekenhuizen - Lokatie Lukas
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Arnhem, Nederländerna, 6815 AD
- Arnhems Radiotherapeutisch Instituut
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Breda, Nederländerna, 4810 EV
- Ziekenhuis de Baronie
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Eindhoven, Nederländerna, 5602 ZA
- Catharina Ziekenhuis
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Harderwijk, Nederländerna, 3840 AC
- Ziekenhuis St Jansdal
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Helmond, Nederländerna, 5707-HA
- Elkerliek Ziekenhuis
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Leiden, Nederländerna, 2300 ZA
- Leiden University Medical Center
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Leiderdorp, Nederländerna, 2350 CC
- Rijnland Ziekenhuis
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Maastricht, Nederländerna, 6202 AZ
- Academisch Ziekenhuis Maastricht
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Nieuwegein, Nederländerna, 3435 CM
- Sint Antonius Ziekenhuis
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Nijmegen, Nederländerna, NL-6252 HB
- University Medical Center Nijmegen
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Rotterdam, Nederländerna, 3000 CA
- University Hospital - Rotterdam Dijkzigt
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Utrecht, Nederländerna, 3508 GA
- Academisch Ziekenhuis Utrecht
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Venlo, Nederländerna, 5900 BX
- St. Maartens Gasthuis
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Zaandam, Nederländerna, 1502 DV
- Ziekenhuis de Heel
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Zwolle, Nederländerna, 8000 GK
- Sophia Ziekehuis
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Gdynia, Polen, PL-81--519
- Maritime Hospital
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Bellinzona, Schweiz, CH-6500
- Ospedale San Giovanni
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spanien
- Hospital Universitario de Getafe
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Johannesburg, Sydafrika, 2193
- Medical Oncology Centre of Rosebank
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Krhanice, Tjeckien, 257 42
- University Hospital Bulovka
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Heidelberg, Tyskland, D-69126
- Thoraxklinik Rohrbach
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS: Histologically confirmed advanced non-small cell lung cancer that is progressive within 2 months prior to study entry Stage IIIB due to malignant pleural effusion or supraclavicular lymph node involvement only Stage IV At least 1 bidimensionally or unidimensionally measurable target lesion Brain metastases or leptomeningeal disease that have been treated with radiotherapy, is stable without medications (e.g., steroids), and asymptomatic are allowed
PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Prothrombin time less than 1.5 times normal Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) (no greater than 2.5 times ULN if due to liver metastases) AST or ALT less than 3 times ULN (no greater than 5 times ULN if due to liver metastases) Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No uncontrolled cardiac disease, sign of cardiac failure, or rhythm disturbances requiring medication No myocardial infarction in the past 3 months Neurological: No preexisting motor or sensory neurotoxicity of grade 2 or greater Other: No active uncontrolled infection Not a poor medical risk due to nonmalignant disease No secondary primary malignancy in the past 5 years (excluding melanoma, breast cancer, and hypernephroma) except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin No psychological condition that might hamper compliance in this study Not pregnant Effective contraception required of all fertile patients during and for 3 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent colony stimulating factor except for secondary prophylaxis in case of infection and severe neutropenia No concurrent immunotherapy Chemotherapy: No prior chemotherapy for advanced disease, including intracavitary chemotherapy At least 1 year since prior neoadjuvant or adjuvant chemotherapy No concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal agents (except corticosteroids for antiemetic prophylaxis) Radiotherapy: Prior radiotherapy should not include all target lesions for evaluation At least 4 weeks since prior radiotherapy Concurrent palliative radiotherapy allowed if indicator lesion is outside of radiation field Surgery: Not specified
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
Samarbetspartners och utredare
Utredare
- Studiestol: Egbert F. Smit, MD, Free University Medical Center
Publikationer och användbara länkar
Allmänna publikationer
- Giaccone G. Gemcitabine plus taxane combinations in non-small cell lung cancer. Semin Oncol. 1999 Feb;26(1 Suppl 4):19-24.
- Efficace F, Bottomley A, Smit EF, Lianes P, Legrand C, Debruyne C, Schramel F, Smit HJ, Gaafar R, Biesma B, Manegold C, Coens C, Giaccone G, Van Meerbeeck J; EORTC Lung Cancer Group and Quality of Life Unit. Is a patient's self-reported health-related quality of life a prognostic factor for survival in non-small-cell lung cancer patients? A multivariate analysis of prognostic factors of EORTC study 08975. Ann Oncol. 2006 Nov;17(11):1698-704. doi: 10.1093/annonc/mdl183. Epub 2006 Sep 12.
- Smit EF, van Meerbeeck JP, Lianes P, Debruyne C, Legrand C, Schramel F, Smit H, Gaafar R, Biesma B, Manegold C, Neymark N, Giaccone G; European Organization for Research and Treatment of Cancer Lung Cancer Group. Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group--EORTC 08975. J Clin Oncol. 2003 Nov 1;21(21):3909-17. doi: 10.1200/JCO.2003.03.195.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Gemcitabin
- Paklitaxel
- Cisplatin
Andra studie-ID-nummer
- EORTC-08975
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