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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

NCT ID: NCT02004093

Last Updated: 2014-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy + Pertuzumab

Group Type EXPERIMENTAL

pertuzumab

Intervention Type DRUG

Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks

paclitaxel

Intervention Type DRUG

175 mg/m2 IV every 3 weeks for 6 cycles

gemcitabine

Intervention Type DRUG

1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles

carboplatin

Intervention Type DRUG

Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles

Chemotherapy

Group Type ACTIVE_COMPARATOR

paclitaxel

Intervention Type DRUG

175 mg/m2 IV every 3 weeks for 6 cycles

gemcitabine

Intervention Type DRUG

1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles

carboplatin

Intervention Type DRUG

Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles

Interventions

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pertuzumab

Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks

Intervention Type DRUG

paclitaxel

175 mg/m2 IV every 3 weeks for 6 cycles

Intervention Type DRUG

gemcitabine

1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles

Intervention Type DRUG

carboplatin

Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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Brussels, , Belgium

Site Status

Leuven, , Belgium

Site Status

Wilrijk, , Belgium

Site Status

Calgary, Alberta, Canada

Site Status

Kelowna, British Columbia, Canada

Site Status

Vancouver, British Columbia, Canada

Site Status

Budapest, , Hungary

Site Status

Debrecen, , Hungary

Site Status

Győr, , Hungary

Site Status

Parma, Emilia-Romagna, Italy

Site Status

Milan, Lombardy, Italy

Site Status

Amsterdam, , Netherlands

Site Status

Amsterdam, , Netherlands

Site Status

Poznan, , Poland

Site Status

Warsaw, , Poland

Site Status

Kazan', , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Tomsk, , Russia

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Birmingham, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Plymouth, , United Kingdom

Site Status

Sutton, , United Kingdom

Site Status

Yeovil, , United Kingdom

Site Status

Countries

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Belgium Canada Hungary Italy Netherlands Poland Russia Spain United Kingdom

Other Identifiers

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BO17931

Identifier Type: -

Identifier Source: org_study_id