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Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

5. mars 2012 oppdatert av: European Organisation for Research and Treatment of Cancer - EORTC

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

450

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Antwerp, Belgia, 2020
        • Algemeen Ziekenhuis Middelheim
  • Egypt
      • Cairo, Egypt
        • National Cancer Institute of Egypt
  • Frankrike
      • Vandoeuvre-Les-Nancy, Frankrike, 54511
        • CHRU de Nancy - Hôpitaux de Brabois
  • Hellas
      • Athens, Hellas, GR-11527
        • Hippokration General Hospital of Athens
  • Italia
      • Biella, Italia, 13900
        • Ospedale Degli Infermi
  • Nederland
      • 's-Gravenhage (Den Haag, The Hague), Nederland, 2545 CH
        • Leyenburg Ziekenhuis
      • 's-Hertogenbosch, Nederland, 5211 NL
        • Groot Ziekengasthuis 's-Hertogenbosch
      • Amsterdam, Nederland, 1105 AZ
        • Academisch Medisch Centrum
      • Amsterdam, Nederland, 1091 HA
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Nederland, 1117 MB
        • Academisch Ziekenhuis der Vrije Universiteit
      • Apeldoorn, Nederland, 7334 DZ
        • Gelre Ziekenhuizen - Lokatie Lukas
      • Arnhem, Nederland, 6815 AD
        • Arnhems Radiotherapeutisch Instituut
      • Breda, Nederland, 4810 EV
        • Ziekenhuis de Baronie
      • Eindhoven, Nederland, 5602 ZA
        • Catharina Ziekenhuis
      • Harderwijk, Nederland, 3840 AC
        • Ziekenhuis St Jansdal
      • Helmond, Nederland, 5707-HA
        • Elkerliek Ziekenhuis
      • Leiden, Nederland, 2300 ZA
        • Leiden University Medical Center
      • Leiderdorp, Nederland, 2350 CC
        • Rijnland Ziekenhuis
      • Maastricht, Nederland, 6202 AZ
        • Academisch Ziekenhuis Maastricht
      • Nieuwegein, Nederland, 3435 CM
        • Sint Antonius Ziekenhuis
      • Nijmegen, Nederland, NL-6252 HB
        • University Medical Center Nijmegen
      • Rotterdam, Nederland, 3000 CA
        • University Hospital - Rotterdam Dijkzigt
      • Utrecht, Nederland, 3508 GA
        • Academisch Ziekenhuis Utrecht
      • Venlo, Nederland, 5900 BX
        • St. Maartens Gasthuis
      • Zaandam, Nederland, 1502 DV
        • Ziekenhuis de Heel
      • Zwolle, Nederland, 8000 GK
        • Sophia Ziekehuis
  • Polen
      • Gdynia, Polen, PL-81--519
        • Maritime Hospital
  • Spania
      • Madrid, Spania, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spania
        • Hospital Universitario de Getafe
  • Sveits
      • Bellinzona, Sveits, CH-6500
        • Ospedale San Giovanni
  • Sør-Afrika
      • Johannesburg, Sør-Afrika, 2193
        • Medical Oncology Centre of Rosebank
  • Tsjekkisk Republikk
      • Krhanice, Tsjekkisk Republikk, 257 42
        • University Hospital Bulovka
  • Tyskland
      • Heidelberg, Tyskland, D-69126
        • Thoraxklinik Rohrbach

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Etterforskere

  • Studiestol: Egbert F. Smit, MD, Free University Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 1998

Primær fullføring (Faktiske)

1. juli 2000

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

12. juli 2004

Først lagt ut (Anslag)

13. juli 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. mars 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mars 2012

Sist bekreftet

1. mars 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EORTC-08975

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