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

Primary Purpose

Ovarian Cancer With Malignant Ascites

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bevacizumab
TC:paclitaxel + carboplatin
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer With Malignant Ascites

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)Female

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.

Sites / Locations

  • First Hospital Affiliated to the PLA General Hospital, Beijing,ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bevacizumab+TC

TC

Arm Description

The treatment group were accepted intraperitoneal injection with bevacizumab (avastin) 300mg after each intraperitoneal hyperthermic perfusion chemotherapy for 6 weeks.

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

Outcomes

Primary Outcome Measures

objective response rate

Secondary Outcome Measures

Full Information

First Posted
April 19, 2013
Last Updated
April 19, 2013
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01838538
Brief Title
Clinical Study in Treatment of Malignant Ascites of Ovarian Cancer With Intraperitoneal Injection Bevacizumab Combined With Intraperitoneal Hyperthermic Perfusion Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer With Malignant Ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab+TC
Arm Type
Experimental
Arm Description
The treatment group were accepted intraperitoneal injection with bevacizumab (avastin) 300mg after each intraperitoneal hyperthermic perfusion chemotherapy for 6 weeks.
Arm Title
TC
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Type
Drug
Intervention Name(s)
TC:paclitaxel + carboplatin
Primary Outcome Measure Information:
Title
objective response rate
Time Frame
24month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Du, PhD
Phone
861068989123
Email
dunan05@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jihua Chen, MD
Phone
862128922576
Email
jihua.chen@roche.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Hui, PhD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Hospital Affiliated to the PLA General Hospital, Beijing,China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Du, PhD
Phone
861068989123
Email
dunan05@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Hui Zhao, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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