Clinical Study in Treatment of Malignant Ascites of Ovarian Cancer With Intraperitoneal Injection Bevacizumab Combined With Intraperitoneal Hyperthermic Perfusion Chemotherapy

April 19, 2013 updated by: DuNan, Chinese PLA General Hospital
To study the efficacy and safety of intraperitoneal injection bevacizumab combined with intraperitoneal hyperthermic perfusion chemotherapy in treatment of malignant ascites of ovarian cancer. To analyze the clinical significance of the concentration change of vascular endothelial growth factor (VEGF) in ascites in treatment of intraperitoneal injection bevacizumab

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100048
        • Recruiting
        • First Hospital Affiliated to the PLA General Hospital, Beijing,China
        • Contact:
        • Principal Investigator:
          • Hui Zhao, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
  • Histologically confirmed and documented ovarian cancer with malignant ascites.
  • ECOG(Eastern Cooperative Oncology Group, ECOG) PS 0-2.
  • Life expectancy of >3 months.
  • No serious inadequate bone marrow function, liver and renal function or significant cardiovascular disease.

Exclusion Criteria:

  • Known hypersensitivity to any of the study drugs or excipients.
  • Any current anti-cancer therapy.
  • No evidence of ascites.
  • Key organ dysfunction.
  • Significant cardiovascular disease (e.g. congestive heart failure (CHF), uncontrolled cardiac arrhythmia, angina, heart valve disease, myocardial infarction and refractory hypertension need to be long time controlled by medicine).
  • Non-healing wound, ulcer or bone fracture.
  • Uncontrolled psychiatric history.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab+TC
The treatment group were accepted intraperitoneal injection with bevacizumab (avastin) 300mg after each intraperitoneal hyperthermic perfusion chemotherapy for 6 weeks.
Drug: Bevacizumab
Drug: TC:paclitaxel + carboplatin
Active Comparator: TC
patients were treated with TC chemotherapy (paclitaxel 135mg/m2 ,iv d1+ carboplatin AUC=5, iv d1), 1 time/3 weeks for 6 weeks, and with intraperitoneal hyperthermic perfusion chemotherapy combined with intraperitoneal cisplatin 40mg/m2，1 time/2 weeks for 6 weeks
Drug: TC:paclitaxel + carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
objective response rate
Time Frame: 24month
24month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Zhao Hui, PhD, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

April 19, 2013

First Submitted That Met QC Criteria

April 19, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 19, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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