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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

149

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

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

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

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
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Kjemoterapi
Legemiddel: paclitaxel
175 mg/m2 IV every 3 weeks for 6 cycles
Legemiddel: gemcitabine
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Legemiddel: carboplatin
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
Eksperimentell: Chemotherapy + Pertuzumab
Legemiddel: pertuzumab
Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks
Legemiddel: paclitaxel
175 mg/m2 IV every 3 weeks for 6 cycles
Legemiddel: gemcitabine
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Legemiddel: carboplatin
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Disease Progression or Death
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year
The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.
1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year
1 year
Percentage of Participants With Disease Progression
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year
1 year
Time To Response
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year
1 year

Samarbeidspartnere og etterforskere

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

Sponsor

Hoffmann-La Roche

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. desember 2005

Primær fullføring (Faktiske)

1. september 2008

Studiet fullført (Faktiske)

1. september 2008

Datoer for studieregistrering

Først innsendt

3. desember 2013

Først innsendt som oppfylte QC-kriteriene

3. desember 2013

Først lagt ut (Anslag)

6. desember 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. desember 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. november 2014

Sist bekreftet

1. november 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BO17931

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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