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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

NCT02004093 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2014-12-04

Study results available
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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.

Conditions

Interventions

DRUG

pertuzumab

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

DRUG

paclitaxel

175 mg/m2 IV every 3 weeks for 6 cycles

DRUG

gemcitabine

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

DRUG

carboplatin

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Belgium
  • Canada
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02004093 on ClinicalTrials.gov