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Safety and Efficacy of Bevacizumab in Combination With Carboplatin and Paclitaxel for Metastatic, Recurrent or Persistent Cervical Cancer

NCT02467907 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2019-06-03

No results posted yet for this study

Summary

This study is to assess safety as defined by the frequency and severity of gastrointestinal (GI) perforation/fistula, GI-vaginal fistula and genitourinary (GU) fistula in participants treated with bevacizumab 15 milligrams per kilogram (mg/kg) in combination with paclitaxel and carboplatin, all repeated every 3 weeks, for recurrent, persistent or metastatic cervical cancer. In addition, this study will include evaluation of the overall safety profile of bevacizumab in combination with paclitaxel and carboplatin in this setting, assessment of GI perforation/fistula, GI-vaginal fistula and GU fistula events over time, and evaluation of efficacy.

Conditions

Interventions

DRUG

Bevacizumab

Intravenous (i.v.) administration of 15 mg/kg bevacizumab once every 3 weeks

DRUG

Carboplatin

Administration of carboplatin at 5 milligrams per milliliter\*minute (mg/mL\*min) on Day 1 every 3 weeks for at least 6 cycles

DRUG

Paclitaxel

Administration of paclitaxel at a dose of 175 milligrams per square meter (mg/m\^2) on Day 1 every 3 weeks for at least 6 cycles

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
2015-07-28
Primary Completion
2018-12-31
Completion
2019-01-15

Countries

  • Argentina
  • Brazil
  • Bulgaria
  • Colombia
  • Costa Rica
  • France
  • Greece
  • Italy
  • Mexico
  • Panama
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Turkey (Türkiye)

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 NCT02467907 on ClinicalTrials.gov