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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
149
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bruxelles, Belgien, 1000
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Leuven, Belgien, 3000
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Wilrijk, Belgien, 2610
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Emilia-Romagna
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Parma, Emilia-Romagna, Italien, 43100
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Lombardia
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Milano, Lombardia, Italien, 20133
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Alberta
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Calgary, Alberta, Kanada, T2N 4N2
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British Columbia
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Kelowna, British Columbia, Kanada, V1Y 5L3
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Vancouver, British Columbia, Kanada, V5Z 4E6
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Amsterdam, Nederländerna, 1081 HV
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Amsterdam, Nederländerna, 1066 CX
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Poznan, Polen, 60-535
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Warszawa, Polen, 02-781
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Kazan, Ryska Federationen, 420029
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Moscow, Ryska Federationen, 125284
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Moscow, Ryska Federationen, 105203
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Moscow, Ryska Federationen, 115478
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Moscow, Ryska Federationen, 143423
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Moscow, Ryska Federationen, 117837
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Saint-Petersburg, Ryska Federationen, 197022
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St Petersburg, Ryska Federationen, 197758
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Tomsk, Ryska Federationen, 634028
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Barcelona, Spanien, 08036
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Barcelona, Spanien, 08035
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Madrid, Spanien, 28041
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Valencia, Spanien, 46009
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Birmingham, Storbritannien, B18 7QH
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London, Storbritannien, W12 OHS
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Manchester, Storbritannien, M20 4BX
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Plymouth, Storbritannien, PL6 8DH
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Sutton, Storbritannien, SM2 5PT
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Yeovil, Storbritannien, BA21 4AT
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Budapest, Ungern, 1122
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Debrecen, Ungern, 4032
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Gyor, Ungern, 9024
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Kemoterapi
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175 mg/m2 IV every 3 weeks for 6 cycles
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
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Experimentell: Chemotherapy + Pertuzumab
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Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks
175 mg/m2 IV every 3 weeks for 6 cycles
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Participants With Disease Progression or Death
Tidsram: 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
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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.
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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
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Progression-Free Survival
Tidsram: 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
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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.
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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
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Kaplan-Meier Probability of No Disease or Progression at 1 Year
Tidsram: 1 year
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The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.
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1 year
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements
Tidsram: 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
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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".
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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
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Duration of Response
Tidsram: 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
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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.
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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
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Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year
Tidsram: 1 year
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1 year
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Percentage of Participants With Disease Progression
Tidsram: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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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.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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Time to Progressive Disease
Tidsram: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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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.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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Kaplan-Meier Probability of Being Progression Free at 1 Year
Tidsram: 1 year
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1 year
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Time To Response
Tidsram: 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
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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.
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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
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Percentage of Participants Who Died
Tidsram: 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
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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
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Overall Survival
Tidsram: 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
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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.
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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
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Kaplan-Meier Probability of Being Alive at 1 Year
Tidsram: 1 year
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1 year
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2005
Primärt slutförande (Faktisk)
1 september 2008
Avslutad studie (Faktisk)
1 september 2008
Studieregistreringsdatum
Först inskickad
3 december 2013
Först inskickad som uppfyllde QC-kriterierna
3 december 2013
Första postat (Uppskatta)
6 december 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 december 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 november 2014
Senast verifierad
1 november 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Carcinom
- Neoplasmer, körtel och epitel
- Genitala neoplasmer, hona
- Sjukdomar i det endokrina systemet
- Ovariella sjukdomar
- Adnexala sjukdomar
- Gonadal sjukdomar
- Neoplasmer i endokrina körtel
- Ovariella neoplasmer
- Karcinom, äggstocksepitel
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Antineoplastiska medel, immunologiska
- Gemcitabin
- Karboplatin
- Paklitaxel
- Pertuzumab
Andra studie-ID-nummer
- BO17931
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .