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Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

30 maart 2015 bijgewerkt door: Sanofi

Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy

Primary Objective:

To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.

Secondary Objectives:

  • To assess disease progression free rate at 12 weeks
  • To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and duration of response
  • To assess Overall Survival (OS)
  • To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC] version 4.03)
  • To assess the Health-Related Quality of Life (HRQoL)

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment.

All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

179

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Brazilië
      • Porto Alegre, Brazilië, 90610-000
        • Investigational Site Number 076001
  • Canada
      • Montreal, Canada, H3T 1E2
        • Investigational Site Number 124003
      • Oshawa, Canada, L1G 2B9
        • Investigational Site Number 124002
      • Rimouski, Canada, G5L 5T1
        • Investigational Site Number 124004
      • Toronto, Canada, M5G 2M9
        • Investigational Site Number 124001
  • Chili
      • Santiago, Chili, 8380456
        • Investigational Site Number 152001
      • Santiago, Chili
        • Investigational Site Number 152005
  • Duitsland
      • Großhansdorf, Duitsland, 22927
        • Investigational Site Number 276003
      • Löwenstein, Duitsland, 74245
        • Investigational Site Number 276006
  • Frankrijk
      • Brest, Frankrijk, 29609
        • Investigational Site Number 250005
      • Caen Cedex, Frankrijk, 14033
        • Investigational Site Number 250004
      • La Tronche, Frankrijk, 38700
        • Investigational Site Number 250006
      • Lille, Frankrijk, 59800
        • Investigational Site Number 250002
      • Saint-Herblain Cedex, Frankrijk, 44805
        • Investigational Site Number 250003
      • Villejuif Cedex, Frankrijk, 94805
        • Investigational Site Number 250007
  • Griekenland
      • Athens, Griekenland, 11522
        • Investigational Site Number 300005
      • Athens, Griekenland, 11527
        • Investigational Site Number 300003
      • Heraklion, Griekenland, 71110
        • Investigational Site Number 300001
      • Thessaloniki, Griekenland, 54629
        • Investigational Site Number 300002
      • Thessaloniki, Griekenland, 57010
        • Investigational Site Number 300004
  • Hongarije
      • Budapest, Hongarije, 1121
        • Investigational Site Number 348001
      • Budapest, Hongarije, 1121
        • Investigational Site Number 348004
      • Budapest, Hongarije, 1125
        • Investigational Site Number 348002
      • Törökbálint, Hongarije, 2045
        • Investigational Site Number 348003
  • Italië
      • Genova, Italië, 16132
        • Investigational Site Number 380001
      • Livorno, Italië, 57123
        • Investigational Site Number 380002
      • Novara, Italië, 28100
        • Investigational Site Number 380005
      • Parma, Italië, 43100
        • Investigational Site Number 380004
  • Korea, republiek van
      • Seoul, Korea, republiek van, 120-752
        • Investigational Site Number 410001
      • Seoul, Korea, republiek van, 135-710
        • Investigational Site Number 410003
      • Seoul, Korea, republiek van, 138-736
        • Investigational Site Number 410002
  • Noorwegen
      • Oslo, Noorwegen, 0440
        • Investigational Site Number 578001
      • Stavanger, Noorwegen, 4011
        • Investigational Site Number 578003
      • Trondheim, Noorwegen, 7006
        • Investigational Site Number 578002
  • Oekraïne
      • Dnipropetrovsk, Oekraïne, 49102
        • Investigational Site Number 804002
      • Donetsk, Oekraïne, 83092
        • Investigational Site Number 804004
      • Lviv, Oekraïne, 70031
        • Investigational Site Number 804001
  • Polen
      • Gdansk, Polen, 80-952
        • Investigational Site Number 616004
      • Lublin, Polen, 20-954
        • Investigational Site Number 616003
      • Poznan, Polen, 60-569
        • Investigational Site Number 616002
      • Warszawa, Polen, 02-781
        • Investigational Site Number 616001
  • Roemenië
      • Cluj Napoca, Roemenië, 400015
        • Investigational Site Number 642003
      • Cluj-Napoca, Roemenië, 400015
        • Investigational Site Number 642005
      • Craiova, Roemenië, 200385
        • Investigational Site Number 642001
      • Timisoara, Roemenië
        • Investigational Site Number 642002
  • Russische Federatie
      • Moscow, Russische Federatie, 115478
        • Investigational Site Number 643001
      • St-Petersburg, Russische Federatie, 197758
        • Investigational Site Number 643005
      • Tula, Russische Federatie, 300053
        • Investigational Site Number 643006
      • Yaroslavl, Russische Federatie, 150054
        • Investigational Site Number 643003
  • Spanje
      • Badalona, Spanje, 08916
        • Investigational Site Number 724002
      • Barcelona, Spanje, 08035
        • Investigational Site Number 724004
      • Málaga, Spanje, 29010
        • Investigational Site Number 724005
      • Valencia, Spanje, 46026
        • Investigational Site Number 724001
  • Verenigde Staten
    • Alabama
      • Muscle Shoals, Alabama, Verenigde Staten, 35661
        • Investigational Site Number 840007
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68114
        • Investigational Site Number 840005
    • New Hampshire
      • Lebanon, New Hampshire, Verenigde Staten, 03756
        • Investigational Site Number 840006
    • Ohio
      • Middletown, Ohio, Verenigde Staten, 45042
        • Investigational Site Number 840003
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Investigational Site Number 840001

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion criteria :

  • Histological/cytological proven locally advanced or metastatic small cell lung cancer with progressive disease during or after first line platinum based chemotherapy
  • Male or female greater than or equal to (>=) 18 years (or country's legal age of majority if greater than [>]18 years)
  • Participants with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 1

Exclusion criteria:

  • Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study
  • More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes
  • Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or surgery to the time of randomization (Radiotherapy for bone pain palliation is allowed)
  • Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization
  • Uncontrolled Central Nervous System (CNS) metastases: participants with CNS metastases may have previous irradiation, only participants with stable disease or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent could be included
  • Participants with known leptomeningeal metastases
  • History of other, invasive neoplasm requiring ongoing therapy
  • Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization
  • Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, stroke or transient ischemic attack
  • Any severe acute or chronic medical condition, which could impair the ability of the participant to participate in the study or interfere with interpretation of study results
  • Known Human Immunodeficiency Virus (HIV) disease, or active hepatitis B or C (systematic testing was not required)
  • Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
  • Participant with reproductive potential (M/F) who did not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" was based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation
  • History of hypersensitivity to polysorbate 80

  • Inadequate organ and bone marrow function as evidenced by:

    • Hemoglobin less than [<] 9.0 gram per deciliter (g/dL)
    • Absolute neutrophil count <1.5 x 10^9 per liter
    • Platelet count <100 x 10^9 per liter
    • Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and/or alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) >2.5 x Upper Limit of Normal (ULN)
    • Alkaline Phosphatase (AP) >2.5 x ULN. In case of liver metastases AP >5 x ULN
    • Total bilirubin >1.0 x ULN
    • Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Collaboration formula, and creatinine clearance <60 milliliter per minute (mL/min) was exclude the participant.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cabazitaxel
Geneesmiddel: Cabazitaxel
Cabazitaxel 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Andere namen:
  • XRP6258
Actieve vergelijker: Topotecan
Geneesmiddel: Topotecan
Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression Free Survival (PFS)
Tijdsspanne: Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival
Tijdsspanne: From randomization to date of death (maximum 15 months)
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve.
From randomization to date of death (maximum 15 months)
Progression Free Rate at Week 12
Tijdsspanne: Week 12
Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported.
Week 12
Overall Objective Tumor Response Rate
Tijdsspanne: Randomization to disease progression/occurrence (maximum 7.6 months)
Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported.
Randomization to disease progression/occurrence (maximum 7.6 months)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sanofi

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2012

Primaire voltooiing (Werkelijk)

1 april 2014

Studie voltooiing (Werkelijk)

1 april 2014

Studieregistratiedata

Eerst ingediend

22 december 2011

Eerst ingediend dat voldeed aan de QC-criteria

27 december 2011

Eerst geplaatst (Schatting)

28 december 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

13 april 2015

Laatste update ingediend die voldeed aan QC-criteria

30 maart 2015

Laatst geverifieerd

1 maart 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ARD12166
  • 2011-003415-31 (EudraCT-nummer)
  • U1111-1123-3503 (Andere identificatie: UTN)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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