Clinical trial NCT02004093: A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Disease Progression or Death
timeFrame: 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
measure: Progression-Free Survival
timeFrame: 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
measure: Kaplan-Meier Probability of No Disease or Progression at 1 Year
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements
timeFrame: 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
measure: Duration of Response
timeFrame: 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
measure: Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year
timeFrame: 1 year
measure: Percentage of Participants With Disease Progression
timeFrame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
measure: Time to Progressive Disease
timeFrame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
measure: Kaplan-Meier Probability of Being Progression Free at 1 Year
timeFrame: 1 year
measure: Time To Response
timeFrame: 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
measure: Percentage of Participants Who Died
timeFrame: 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
measure: Overall Survival
timeFrame: 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
measure: Kaplan-Meier Probability of Being Alive at 1 Year
timeFrame: 1 year
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Wilrijk
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Parma
country: Italy
state: Emilia-Romagna
city: Milano
country: Italy
state: Lombardia
city: Amsterdam
country: Netherlands
city: Amsterdam
country: Netherlands
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Birmingham
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Sutton
country: United Kingdom
city: Yeovil
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: