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A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer

25 november 2014 bijgewerkt door: Hoffmann-La Roche

A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer

This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

149

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

  • België
      • Bruxelles, België, 1000
      • Leuven, België, 3000
      • Wilrijk, België, 2610
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
      • Vancouver, British Columbia, Canada, V5Z 4E6
  • Hongarije
      • Budapest, Hongarije, 1122
      • Debrecen, Hongarije, 4032
      • Gyor, Hongarije, 9024
  • Italië
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italië, 43100
    • Lombardia
      • Milano, Lombardia, Italië, 20133
  • Nederland
      • Amsterdam, Nederland, 1081 HV
      • Amsterdam, Nederland, 1066 CX
  • Polen
      • Poznan, Polen, 60-535
      • Warszawa, Polen, 02-781
  • Russische Federatie
      • Kazan, Russische Federatie, 420029
      • Moscow, Russische Federatie, 125284
      • Moscow, Russische Federatie, 105203
      • Moscow, Russische Federatie, 115478
      • Moscow, Russische Federatie, 143423
      • Moscow, Russische Federatie, 117837
      • Saint-Petersburg, Russische Federatie, 197022
      • St Petersburg, Russische Federatie, 197758
      • Tomsk, Russische Federatie, 634028
  • Spanje
      • Barcelona, Spanje, 08036
      • Barcelona, Spanje, 08035
      • Madrid, Spanje, 28041
      • Valencia, Spanje, 46009
  • Verenigd Koninkrijk
      • Birmingham, Verenigd Koninkrijk, B18 7QH
      • London, Verenigd Koninkrijk, W12 OHS
      • Manchester, Verenigd Koninkrijk, M20 4BX
      • Plymouth, Verenigd Koninkrijk, PL6 8DH
      • Sutton, Verenigd Koninkrijk, SM2 5PT
      • Yeovil, Verenigd Koninkrijk, BA21 4AT

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

Vrouw

Beschrijving

Inclusion Criteria:

  • histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
  • only 1 previous regimen, which must be platinum-based;
  • platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.

Exclusion Criteria:

  • previous radiotherapy;
  • previous treatment with an anti-cancer vaccine or any targeted therapy;
  • major surgery or traumatic injury within 4 weeks of study;
  • history or evidence of central nervous system metastases.

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
Actieve vergelijker: Chemotherapie
Geneesmiddel: paclitaxel
175 mg/m2 IV every 3 weeks for 6 cycles
Geneesmiddel: gemcitabine
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Geneesmiddel: carboplatin
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
Experimenteel: Chemotherapy + Pertuzumab
Geneesmiddel: pertuzumab
Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks
Geneesmiddel: paclitaxel
175 mg/m2 IV every 3 weeks for 6 cycles
Geneesmiddel: gemcitabine
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Geneesmiddel: carboplatin
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Disease Progression or Death
Tijdsspanne: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Progression-Free Survival
Tijdsspanne: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Kaplan-Meier Probability of No Disease or Progression at 1 Year
Tijdsspanne: 1 year
The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.
1 year

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements
Tijdsspanne: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were "response", "stable disease" and "progressive disease". Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of "response" or "progressive disease".
Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Duration of Response
Tijdsspanne: Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks
For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.
Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year
Tijdsspanne: 1 year
1 year
Percentage of Participants With Disease Progression
Tijdsspanne: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
Time to Progressive Disease
Tijdsspanne: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.
Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
Kaplan-Meier Probability of Being Progression Free at 1 Year
Tijdsspanne: 1 year
1 year
Time To Response
Tijdsspanne: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events.
Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Percentage of Participants Who Died
Tijdsspanne: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Overall Survival
Tijdsspanne: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.
Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Kaplan-Meier Probability of Being Alive at 1 Year
Tijdsspanne: 1 year
1 year

Medewerkers en onderzoekers

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

Sponsor

Hoffmann-La Roche

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 december 2005

Primaire voltooiing (Werkelijk)

1 september 2008

Studie voltooiing (Werkelijk)

1 september 2008

Studieregistratiedata

Eerst ingediend

3 december 2013

Eerst ingediend dat voldeed aan de QC-criteria

3 december 2013

Eerst geplaatst (Schatting)

6 december 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

4 december 2014

Laatste update ingediend die voldeed aan QC-criteria

25 november 2014

Laatst geverifieerd

1 november 2014

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BO17931

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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