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A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer

NCT00937560 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2017-11-06

Study results available
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Summary

This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m\^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.

Conditions

Interventions

DRUG

Bevacizumab

Bevacizumab was supplied as a sterile solution for infusion.

DRUG

Paclitaxel

Paclitaxel was supplied locally in commercial batches.

DRUG

Carboplatin

Carboplatin was supplied locally in commercial batches.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-25
Primary Completion
2012-07-31
Completion
2013-07-01

Countries

  • Brazil
  • France
  • Italy
  • Netherlands
  • Norway
  • Russia
  • Spain
  • Sweden
  • 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 NCT00937560 on ClinicalTrials.gov