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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 2

Conditions: Ovarian Cancer With Malignant Ascites

Treatments: Drug: Bevacizumab; Drug: TC:paclitaxel + carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01838538

ML25396

Details and patient eligibility

About

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

Enrollment: 54 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Bevacizumab+TC

Experimental group

Description:

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

Treatment:

Drug: TC:paclitaxel + carboplatin

Drug: Bevacizumab

TC

Active Comparator group

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

Treatment:

Drug: TC:paclitaxel + carboplatin