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

Phase 2

• Conditions: Ovarian Cancer With Malignant Ascites
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01838538
• Lead Sponsor: Chinese PLA General Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Status Verified: 2013-04
• Study First Submitted: 2013-04-19
• Study First Submitted QC: 2013-04-19
• Last Update Submitted: 2013-04-19
• Study First Posted: 2013-04-24
• Last Update Posted: 2013-04-24
• Primary Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 54

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bevacizumab+TC	Bevacizumab	The treatment group were accepted intraperitoneal injection with bevacizumab (avastin) 300mg after each intraperitoneal hyperthermic perfusion chemotherapy for 6 weeks.

Primary Outcome Measures

Name	Time	Method
objective response rate	24month

Trial Locations

Locations (1)

First Hospital Affiliated to the PLA General Hospital, Beijing,China; 🇨🇳 Beijing, Beijing, China