Clinical Study in Treatment of Malignant Ascites of Ovarian Cancer With Intraperitoneal Injection Bevacizumab Combined With Intraperitoneal Hyperthermic Perfusion Chemotherapy
NCT ID: NCT01838538
Last Updated: 2013-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
54 participants
INTERVENTIONAL
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bevacizumab+TC
The treatment group were accepted intraperitoneal injection with bevacizumab (avastin) 300mg after each intraperitoneal hyperthermic perfusion chemotherapy for 6 weeks.
Bevacizumab
TC:paclitaxel + carboplatin
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
TC:paclitaxel + carboplatin
Interventions
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Bevacizumab
TC:paclitaxel + carboplatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
FEMALE
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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DuNan
Chief Physician
Principal Investigators
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Zhao Hui, PhD
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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First Hospital Affiliated to the PLA General Hospital, Beijing,China
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Other Identifiers
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ML25396
Identifier Type: -
Identifier Source: org_study_id
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