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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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

450

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 1998

Primær færdiggørelse (Faktiske)

1. juli 2000

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

12. juli 2004

Først opslået (Skøn)

13. juli 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. marts 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. marts 2012

Sidst verificeret

1. marts 2012

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lungekræft

Kliniske forsøg med cisplatin

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Abonner