A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
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
1 other identifier
interventional
149
9 countries
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Dec 2005
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedResults Posted
Study results publicly available
December 4, 2014
CompletedDecember 4, 2014
November 1, 2014
2.8 years
December 3, 2013
July 31, 2014
November 25, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Participants With Disease Progression or Death
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
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
The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.
1 year
Secondary Outcomes (10)
Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements
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
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
1 year
Percentage of Participants With Disease Progression
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
Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
- +5 more secondary outcomes
Study Arms (2)
Chemotherapy + Pertuzumab
EXPERIMENTALChemotherapy
ACTIVE COMPARATORInterventions
Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
Brussels, 1000, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Wilrijk, 2610, Belgium
Unknown Facility
Calgary, Alberta, T2N 4N2, Canada
Unknown Facility
Kelowna, British Columbia, V1Y 5L3, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 4E6, Canada
Unknown Facility
Budapest, 1122, Hungary
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Győr, 9024, Hungary
Unknown Facility
Parma, Emilia-Romagna, 43100, Italy
Unknown Facility
Milan, Lombardy, 20133, Italy
Unknown Facility
Amsterdam, 1066 CX, Netherlands
Unknown Facility
Amsterdam, 1081 HV, Netherlands
Unknown Facility
Poznan, 60-535, Poland
Unknown Facility
Warsaw, 02-781, Poland
Unknown Facility
Kazan', 420029, Russia
Unknown Facility
Moscow, 105203, Russia
Unknown Facility
Moscow, 115478, Russia
Unknown Facility
Moscow, 117837, Russia
Unknown Facility
Moscow, 125284, Russia
Unknown Facility
Moscow, 143423, Russia
Unknown Facility
Saint Petersburg, 197022, Russia
Unknown Facility
Saint Petersburg, 197758, Russia
Unknown Facility
Tomsk, 634028, Russia
Unknown Facility
Barcelona, Barcelona, 08035, Spain
Unknown Facility
Barcelona, Barcelona, 08036, Spain
Unknown Facility
Madrid, Madrid, 28041, Spain
Unknown Facility
Valencia, Valencia, 46009, Spain
Unknown Facility
Birmingham, B18 7QH, United Kingdom
Unknown Facility
London, W12 OHS, United Kingdom
Unknown Facility
Manchester, M20 4BX, United Kingdom
Unknown Facility
Plymouth, PL6 8DH, United Kingdom
Unknown Facility
Sutton, SM2 5PT, United Kingdom
Unknown Facility
Yeovil, BA21 4AT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann- LaRoche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2013
First Posted
December 6, 2013
Study Start
December 1, 2005
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
December 4, 2014
Results First Posted
December 4, 2014
Record last verified: 2014-11