Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer

NCT01802749 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2023-03-24

No results posted yet for this study

Summary

Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab.

Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined.

This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.

Conditions

  • Recurrent Ovarian Cancer

Interventions

DRUG

Paclitaxel

DRUG

pegylated liposomal doxorubicin

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER
  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Sandro Pignata, M.D., Ph.D. · National Cancer Institute, Naples

  • Nicoletta Colombo, M.D. · European Institute of Oncology

  • Francesco Perrone, M.D., Ph.D. · National Cancer Institute, Naples

  • Gennaro Daniele, M.D., Ph.D. · National Cancer Institute, Naples

  • Roldano Fossati, M.D. · Mario Negri Institute

  • Ciro Gallo, M.D. · University of Campania Luigi Vanvitelli

  • Irene Floriani, Ph.D. · Mario Negri Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • France
  • Greece
  • Italy
  • Monaco
  • Switzerland

Study Locations

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Entities

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 NCT01802749 on ClinicalTrials.gov