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Bevacizumab in Extensive Small Cell Lung Cancer (CPC)

9. marts 2016 opdateret af: Intergroupe Francophone de Cancerologie Thoracique

Randomized Phase II-III Study of Bevacizumab 7,5 mg/kg in Combination With Chemotherapy Versus Chemotherapy in Extensive-Disease Small-Cell Lung Cancer After Response to Chemotherapy : PCDE (cisPlatin - Cyclophosphamide - epiDoxorubicin - Etoposide) or PE (cisPlatin - Etoposide)

Despite the fact that a substantial response rate may be obtained in small-cell lung cancers (using double-drug chemotherapy: cisplatin-etoposide, PE), a cure remains an exception. More aggressive regimens remain controversial and recent attempts at increasing dose-intensity have been restricted to patients with a more favourable presentation.

Bevacizumab is a humanized monoclonal antibody which binds to VEGF (Vascular Endothelial Growth Factor). In association with double-drug standard chemotherapies, it has been proven that bevacizumab can improve survival of previously untreated advanced non-small-cell lung cancers (NSCLC), compared to chemotherapy without bevacizumab). Such promising effects on NSCLC deserve to be tested on small-cell lung cancers.

In this trial (IFCT-0802), standard chemotherapy (PCDE or PE) will be compared to experimental treatment (PCDE or PE + bevacizumab 7.5 mg/kg) for previously untreated SCLC patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

143

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Frankrig
      • Ambilly, Frankrig, 74100
        • Annemasse - CH
      • Angers, Frankrig, 49000
        • Angers - CHU
      • Armentières, Frankrig
        • Armentières - CH
      • Besancon, Frankrig, 25000
        • CHU Besancon - Pneumologie
      • Caen, Frankrig, 14000
        • Centre F. Baclesse
      • Caen, Frankrig, 14000
        • CHU - Pneumologie
      • Cahors, Frankrig, 46000
        • Cahors - CH
      • Chalons-en-Champagne, Frankrig
        • Chalons-en-Champagne - CH
      • Chauny, Frankrig
        • Chauny - CH
      • Clamart, Frankrig, 92140
        • Hôpital Percy-Armées - Pneumologie
      • Clermont Ferrand, Frankrig, 63000
        • Clermont Ferrand - CHU
      • Colmar, Frankrig, 68000
        • Colmar - CH
      • Compiègne, Frankrig, 60300
        • CH - Compiegne
      • Créteil, Frankrig, 94000
        • Créteil - CHI
      • Dijon, Frankrig, 21000
        • Dijon - CAC
      • Dijon, Frankrig, 63000
        • Dijon - CHU
      • Draguignan, Frankrig, 83300
        • Draguignan - CH
      • Grenoble, Frankrig, 38000
        • CHU Grenoble - pneumologie
      • Harfleur, Frankrig, 76700
        • Harfleur - Clinique du Petit Colmoulins
      • Helfaut, Frankrig, 62570
        • Saint Omer - CHI
      • Jonzac, Frankrig, 17500
        • Jonzac - CH
      • Le Coudray, Frankrig, 28630
        • Chartres - CH
      • Le Mans, Frankrig, 72000
        • Centre Hospitalier - Pneumologie
      • Longjumeau, Frankrig
        • CH
      • Marseille, Frankrig, 13000
        • APHM - Hôpital Sainte Marguerite
      • Marseille, Frankrig
        • Marseille - CRLCC
      • Maubeuge, Frankrig, 59600
        • Maubeuge - Polyclinique du Parc
      • Meaux, Frankrig, 77100
        • Meaux - CH
      • Metz, Frankrig, 57000
        • Metz - CHR
      • Mont de Marsan, Frankrig, 40000
        • Mont de Marsan - CH
      • Montpellier, Frankrig, 34295
        • Montpellier - CHRU
      • Mulhouse, Frankrig, 68000
        • Mulhouse - CH
      • Neuilly, Frankrig, 92200
        • Neuilly - Hôpital Américain de Paris
      • Nevers, Frankrig, 58033
        • Nevers - CH
      • Nice, Frankrig, 06000
        • Nice - CAC
      • Orléans, Frankrig, 45000
        • Orléans - CH
      • Paris, Frankrig, 75012
        • APHP - Saint-Antoine - pneumologie
      • Paris, Frankrig, 75020
        • APHP - Hopital Tenon - Pneumologie
      • Pau, Frankrig, 64046
        • Pau - CH
      • Pierre Bénite, Frankrig, 69495
        • HCL - Lyon Sud (Pneumologie)
      • Reims, Frankrig, 51092
        • Reims - CHU
      • Reims, Frankrig
        • Reims - CRLCC
      • Rouen, Frankrig, 76000
        • Rouen - CHU
      • Saint Brieuc, Frankrig, 22000
        • Saint Brieuc - CHG
      • Saint Nazaire, Frankrig, 44600
        • Saint Nazaire - Centre Etienne Dolet
      • Saint Priest en Jarez, Frankrig, 42270
        • Saint Priest en Jarez - ICL
      • Saint Quentin, Frankrig, 02100
        • Saint Quentin - CH
      • Saverne, Frankrig
        • Saverne - CH
      • Senlis, Frankrig, 60300
        • Senlis - CH
      • Strasbourg, Frankrig, 63000
        • Nouvel Hopital Civil - Pneumologie
      • Suresnes, Frankrig, 92151
        • Suresnes - Hopital Foch
      • Thonon les bains, Frankrig, 74200
        • Thonon les bains
      • Toulon, Frankrig, 83000
        • Toulon - HIA
      • Toulouse, Frankrig
        • CHU Toulouse - Pneumologie
      • Toulouse, Frankrig
        • Toulouse - Clinique Pasteur
      • Tours, Frankrig, 37000
        • Tours - CHU
      • Vandoeuvre lès Nancy, Frankrig, 54500
        • Nancy - CHU
      • Verdun, Frankrig
        • Verdun - CHG
      • Vesoul, Frankrig, 70000
        • Vesoul - CHI
      • Villejuif, Frankrig, 94800
        • Institut Gustave Roussy

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

Inclusion Criteria (must be checked at the inclusion, week -8):

  • Small-Cell Lung Cancer histologically or cytologically proved
  • Extended disease as defined by Veteran's Administration Lung Cancer Group (VALG)
  • At least one unidimensionally measurable lesion (RECIST criterion)
  • Age between 18 and 75 years
  • Weight loss < 10% for the last three month
  • Performance Status (PS)≤ 2
  • Creatininemia < 110 µmol/L and creatinin clearance > 60 mL/min
  • Neutrophils ≥ 1,500/µL and platelets ≥ 100,000/µL
  • Bilirubin ≤ 1.5 x normal value
  • Transaminases, Alkaline Phosphatase ≤ 2.5 x ULN excepted in case of liver metastasis (5xULN)
  • Left ventricular ejection fraction (measured by echocardiographic or isotopic method) > 50% if PCDE is planned
  • Electrocardiogram without uncontrolled coronaropathy
  • Signed informed consent

Randomization Criteria (to be checked during the randomization (week 0)):

  • Partial or complete tumoral response as defined by RECIST
  • All chemotherapy-induced toxicities decreased to level ≤ 2 as defined by NCI CTC VS 3 (except for alopecia)
  • Inclusion criteria concerning creatininemia, clearance, neutrophils, platelets, transaminases, alkaline phosphatases and left ventricular ejection fraction must be checked again

Exclusion Criteria:

  • Non-Small-Cell Lung Cancer or mixed cancer (small-cell / non-small-cell)
  • Previous antitumoral treatment of the small-cell lung cancer (chemotherapy, radiotherapy, immunotherapy, surgery)
  • Non-extended disease as defined by VALG
  • Natremia < 125 mmol/L
  • Hypercalcemia whereas a corrective treatment
  • Pathology contra-indicating the hyper-hydration
  • Hemoptysis in the last three months
  • Tumor invading large vessels or invading the proximal trachea-bronchial tree (visible at the medical imagery). Investigator or radiologist must reject tumors adjoining, merging or extending to large vessel's lumen (for example : pulmonary artery, superior vena cava)
  • Symptomatic cerebral or meningeal metastasis
  • Other cancer in progress or medical history of cancer in the five last years (excepted basal cell carcinoma or in situ cervical cancer of the uterus.
  • Important surgical intervention (including surgical biopsy), traumatic lesion during 28 days before starting the treatment, or anticipation of an important surgical intervention during the study
  • Minor surgical intervention, including implanting permanent catheter during the 24 hours before the first administration of bevacizumab
  • Unhealed wound, evolutive gastroduodenal ulcer, fractured bone
  • Medical history of abdominal fistula, trachea-oesophageal fistula, of another type with a severity rank of 4, gastrointestinal perforation or intraabdominal abscess during 6 month before inclusion
  • Ongoing or recent use of aspirin (during 10 days before the first administration of bevacizumab) (>325 mg/day) or use of another platelet aggregation inhibitor (dipyridamole, ticlopidine, clopidogrel > 75 mg/day), or ongoing or recent use of a therapeutic dose (during 10 days before the first administration of bevacizumab) of anticoagulant or thrombolytic drugs per os or in parenteral injection. Prophylactic use of anticoagulant drug is allowed
  • Medical history or genetic predisposition to bleeding or coagulopathy
  • Clinically significative cardiac disease: infarct or CVA during 6 month before inclusion, unstable angina, congestive cardiac failure level > II as defined by New York Heart Association (NYHA) or cardiac arrythmia needing a specific treatment which risk to interfere with the study, or uncontrolled arrythmia.
  • Known allergy or hypersensibility to monoclonal antibodies (bevacizumab), to chinese hamster ovary cells or to any humanized or recombinant antibody
  • Uncontrolled high blood pressure (systolic pressure > 150 mm Hg and/or diastolic pressure > 100 mm Hg), with or without hypotension treatment. Patients presenting an high blood pressure are eligibles if their treatment can decrease their blood pressure to the values required by the protocol.
  • Severe ongoing infectious disease or fever > 38.5°C or evidence of any other pathology, organic or neurologic functions deterioration, physical examination or laboratory result which cause suspicion of a disease which contra-indicate use of any studied treatment.
  • Woman with a positive pregnancy test or who has not made a pregnancy test (unless pregnancy risk can be excluded)
  • Lactating woman
  • Sexually active woman who don't use hormonal or mechanical contraceptive method or sexually active man who has a sexually active partner who don't want to use an effective contraceptive method during the course of the study and during the 6 months after last treatment administration
  • Patient who as already been included and treated in the present study
  • Patient who participate or who has participated in another study during 4 weeks before treatment administration
  • Patient who receive a previous antiangiogenic treatment (experimental or commercial : bevacizumab, thalidomide, CP-547632, sunitinib, sorafenib...)
  • Geographical or psychological condition which not allowed a good comprehension or compliance to protocol
  • Liberty deprived patient

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
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm A
4 additional cycles of chemotherapy
Medicin: Standard Chemotherapy (PCDE or PE)

PCDE: cisPlatin 75 mg/m² D2 ; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 4 cycles

PE: cisPlatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 4 cycles

Medicin: Prerandomization Chemotherapy (PCDE or PE)

PCDE: cisPlatin 75 mg/m² D2; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 2 cycles

PE: cisplatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 2 cycles
Eksperimentel: Arm B
4 additional cycles of chemotherapy + bevacizumab
Medicin: Prerandomization Chemotherapy (PCDE or PE)

PCDE: cisPlatin 75 mg/m² D2; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 2 cycles

PE: cisplatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 2 cycles

Medicin: Experimental Treatment (PCDE or PE + bevacizumab)

PCDE: cisPlatin 75 mg/m² D2; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 4 cycles Bevacizumab 7.5 mg/kg, D1, until progression

PE: cisPlatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 4 cycles Bevacizumab 7.5 mg/kg, D1, until progression

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Response rate (complete response + partial response)
Tidsramme: 6 weeks after randomization
6 weeks after randomization

Sekundære resultatmål

Resultatmål
Tidsramme
Progression-free survival
Tidsramme: 12 weeks
12 weeks
Complete response length
Tidsramme: 12 weeks
12 weeks
Livskvalitet
Tidsramme: 12 uger
12 uger
Toxicities
Tidsramme: 12 weeks
12 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Efterforskere

  • Ledende efterforsker: Jean-Louis PUJOL, Pr, CHRU Montpellier

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.

Generelle publikationer

Hjælpsomme links

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. september 2009

Primær færdiggørelse (Faktiske)

1. juli 2012

Studieafslutning (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først indsendt

1. juli 2009

Først indsendt, der opfyldte QC-kriterier

1. juli 2009

Først opslået (Skøn)

2. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IFCT-0802
  • 2009-010187-42

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Ingen

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 .

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