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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 2

Conditions: Peritoneal Adhesion

Treatments: Drug: paclitaxel; Drug: Bevacizumab; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03095001

Intraperitoneal bev

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathologically and radiologically confirmed stage IV or postoperative recurrence ovarian cancer.
2. Age of 18-70, Karnofsky score higher than 80.
3. No severe functional damage of major organ, normal liver and kidney function.
4. 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

1. Complete intestinal obstruction and suitable for surgery.

2. Patients known to be allergic to bevacizumab or any of the components of the drug.

3. Other ongoing anti-tumor treatment.

4. 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

5. Active wound infection and a history of uncontrolled psychiatric illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Intraperitoneal bevacizumab+ carboplatin

Experimental group

Description:

Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles

Treatment:

Drug: Carboplatin

Drug: Bevacizumab

Drug: paclitaxel

Intraperitoneal carboplatin

Active Comparator group

Description:

Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles

Treatment:

Drug: Carboplatin

Drug: paclitaxel