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A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

NCT00698451 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2013-09-06

Study results available
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Summary

The purpose of this study is to evaluate the response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten 28-day cycles. Patients will be followed for six months following treatment to assess progression-free survival.

Conditions

  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms

Interventions

DRUG

doxorubicin HCL liposome; bevacizumab; carboplatin

30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle

Sponsors & Collaborators

  • Centocor Ortho Biotech Services, L.L.C.

    collaborator INDUSTRY

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Tracey McGowan, MD · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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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 NCT00698451 on ClinicalTrials.gov