Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion

Study Overview
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Brief Summary
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Background: Malignant peritoneal adhesion is a common complication and prognostic factor of ovarian cancer and other primary abdominal tumors. The incidence of peritoneal adhesion in advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the recent decade. Malignant peritoneal adhesion is closely associated with the morbidity and mortality of malignant intestinal obstruction. The peritoneal adhesion may aggravates the abdominal symptoms and reduce quality of life. Further, the peritoneal adhesion may impede treatment of primary tumor, such as operation or chemotherapy, lead to a poor prognosis. Objective: This study aims to treat malignant peritoneal adhesion with the combination of antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal antiangiogenic agent plus chemotherapy. As explosive endpoints, we will examination the expression of VEGF-A in peritoneal cavity during the treatment.

Official Title
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Chinese PLA Generation Hospital

Conditions
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Peritoneal Adhesion

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Carboplatin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically and radiologically confirmed stage IV or postoperative recurrence ovarian cancer. Age of 18-70, Karnofsky score higher than 80. No severe functional damage of major organ, normal liver and kidney function. Peritoneal adhesion. (1) peritoneal adhesions diagnosed by microlaparoscopy or abdominal operations, and classification according to Nair criteria is performed. (1) must be met. (2) Peritoneal adhesion symptoms, intermittent abdominal pain, abdominal distension, nausea and vomiting, hard to pass stools or gas; (3) Peritoneal adhesion signs，abdominal distension, abdominal tenderness, reduced or absent bowel sounds; (4) B ultrasound or CT or MRI show peritoneal adhesion or adhesion-related complications. Exclusion Criteria: Complete intestinal obstruction and suitable for surgery. Patients known to be allergic to bevacizumab or any of the components of the drug. Other ongoing anti-tumor treatment. Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure Active wound infection and a history of uncontrolled psychiatric illness. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraperitoneal bevacizumab+ carboplatin<br>Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles | Drug: Bevacizumab<br>* Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles<br>* Other names: Avastin;Drug: Carboplatin<br>* carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles<br>Drug: paclitaxel<br>* paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles<br>|
| Active Comparator: Intraperitoneal carboplatin<br>Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles | Drug: Carboplatin<br>* carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles<br>Drug: paclitaxel<br>* paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritoneal adhesion ORR (pORR) | Degree of adhesion was measured according to NAIR's criteria by laparoscopy. Grade 0 corresponded to no adhesions, Grade 1 and 2 corresponded to filmy adhesions and grade 3 and 4 to dense adhesions. No adhesions is defined as CR, dense adhesions change to filmy adhesions is defined as PR. The total efficiency ORR was calculated by taking the sum of CR+PR. | 3weeks after the last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Adverse Events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From first dose up to 1 month after the last treatment | 
| Quality of Life (QoL) | Quality of Life (QoL) assessed by FACT-O | From first dose up to 1 year | 
| Progression free survival (PFS) | From randomization until documented progressive disease or death | Up to 3 years | 
| Overall survival (OS) | From randomization until death | Up to 3 years | 
| Objective Response Rate (ORR) | The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1. | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bevacizumab, Intraperitoneal administration, Ovarian Cancer, Peritoneal Adhesion