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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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

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Conditions

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Ovarian Cancer With Malignant Ascites

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

TC:paclitaxel + carboplatin

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

TC:paclitaxel + carboplatin

Intervention Type DRUG

Interventions

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Bevacizumab

Intervention Type DRUG

TC:paclitaxel + carboplatin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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DuNan

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Nan Du, PhD

Role: CONTACT

861068989123

Jihua Chen, MD

Role: CONTACT

862128922576

Facility Contacts

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Nan Du, PhD

Role: primary

861068989123

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.

Reference Type DERIVED
PMID: 37185961 (View on PubMed)

Other Identifiers

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ML25396

Identifier Type: -

Identifier Source: org_study_id

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