Status:
UNKNOWN
Clinical Study in Treatment of Malignant Ascites of Ovarian Cancer With Intraperitoneal Injection Bevacizumab Combined With Intraperitoneal Hyperthermic Perfusion Chemotherapy
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Ovarian Cancer With Malignant Ascites
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 anal...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01838538
Start Date
June 1 2011
Last Update
April 24 2013
Active Locations (1)
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1
First Hospital Affiliated to the PLA General Hospital, Beijing,China
Beijing, Beijing Municipality, China, 100048