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

Primary Purpose

Peritoneal Adhesion

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bevacizumab
Carboplatin
paclitaxel
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Adhesion focused on measuring bevacizumab, Intraperitoneal administration, Ovarian Cancer, Peritoneal Adhesion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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.

    -

Sites / Locations

  • First Affiliated Hospital, Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intraperitoneal bevacizumab+ carboplatin

Intraperitoneal carboplatin

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Patients with Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Quality of Life (QoL)
Quality of Life (QoL) assessed by FACT-O
Progression free survival (PFS)
From randomization until documented progressive disease or death
Overall survival (OS)
From randomization until death
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.

Full Information

First Posted
March 16, 2017
Last Updated
April 11, 2017
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03095001
Brief Title
Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion
Official Title
Chinese PLA Generation Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Adhesion
Keywords
bevacizumab, Intraperitoneal administration, Ovarian Cancer, Peritoneal Adhesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraperitoneal bevacizumab+ carboplatin
Arm Type
Experimental
Arm 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
Arm Title
Intraperitoneal carboplatin
Arm Type
Active Comparator
Arm Description
Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles
Primary Outcome Measure Information:
Title
Peritoneal adhesion ORR (pORR)
Description
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.
Time Frame
3weeks after the last treatment
Secondary Outcome Measure Information:
Title
Number of Patients with Adverse Events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
From first dose up to 1 month after the last treatment
Title
Quality of Life (QoL)
Description
Quality of Life (QoL) assessed by FACT-O
Time Frame
From first dose up to 1 year
Title
Progression free survival (PFS)
Description
From randomization until documented progressive disease or death
Time Frame
Up to 3 years
Title
Overall survival (OS)
Description
From randomization until death
Time Frame
Up to 3 years
Title
Objective Response Rate (ORR)
Description
The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1.
Time Frame
Up to 1 year
Other Pre-specified Outcome Measures:
Title
Expression of VEGF-A in peritoneal cavity
Description
Quantitation of VEGF-A by enzyme-linked immunosorbent assay (ELISA), before and after intraperitoneal administration.
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Du, PhD
Email
dunan304@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan Du, PhD
Organizational Affiliation
PLA 304 hospital
Official's Role
Study Director
Facility Information:
Facility Name
First Affiliated Hospital, Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhao, Phd
First Name & Middle Initial & Last Name & Degree
Nan Du, Phd

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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