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

Phase 2

• Conditions: Peritoneal Adhesion
• Interventions: Drug: Bevacizumab; Drug: Carboplatin; Drug: paclitaxel

• Registration Number: NCT03095001
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-13
• Study Start: 2017-06-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraperitoneal bevacizumab+ carboplatin	Carboplatin	Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
Intraperitoneal bevacizumab+ carboplatin	Bevacizumab	Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
Intraperitoneal bevacizumab+ carboplatin	paclitaxel	Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
Intraperitoneal carboplatin	Carboplatin	Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
Intraperitoneal carboplatin	paclitaxel	Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles

Primary Outcome Measures

Name	Time	Method
Peritoneal adhesion ORR (pORR)	3weeks after the last treatment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Affiliated Hospital, Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China