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

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ClinicalTrials.gov Identifier: NCT03095001
Recruitment Status : Unknown
Verified April 2017 by DuNan, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : March 29, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
DuNan, 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.


Condition or disease Intervention/treatment Phase
Peritoneal Adhesion Drug: Bevacizumab Drug: Carboplatin Drug: paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Chinese PLA Generation Hospital
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020


Arm Intervention/treatment
Experimental: Intraperitoneal bevacizumab+ 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

Drug: Bevacizumab
Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles
Other Name: Avastin

Drug: Carboplatin
carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles

Drug: paclitaxel
paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles

Active Comparator: Intraperitoneal carboplatin

Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks

Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles

Drug: Carboplatin
carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles

Drug: paclitaxel
paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles




Primary Outcome Measures :
  1. Peritoneal adhesion ORR (pORR) [ Time Frame: 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 :
  1. Number of Patients with Adverse Events [ Time Frame: 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

  2. Quality of Life (QoL) [ Time Frame: From first dose up to 1 year ]
    Quality of Life (QoL) assessed by FACT-O

  3. Progression free survival (PFS) [ Time Frame: Up to 3 years ]
    From randomization until documented progressive disease or death

  4. Overall survival (OS) [ Time Frame: Up to 3 years ]
    From randomization until death

  5. Objective Response Rate (ORR) [ Time Frame: 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.


Other Outcome Measures:
  1. Expression of VEGF-A in peritoneal cavity [ Time Frame: Up to 1 year ]
    Quantitation of VEGF-A by enzyme-linked immunosorbent assay (ELISA), before and after intraperitoneal administration.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095001


Contacts
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Contact: Nan Du, PhD dunan304@163.com

Locations
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China, Beijing
First Affiliated Hospital, Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100048
Contact: Hui Zhao, Phd         
Principal Investigator: Nan Du, Phd         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Director: Nan Du, PhD PLA 304 hospital
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Responsible Party: DuNan, Director of oncology, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03095001    
Other Study ID Numbers: Intraperitoneal bev
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Keywords provided by DuNan, Chinese PLA General Hospital:
bevacizumab
Intraperitoneal administration
Ovarian Cancer
Peritoneal Adhesion
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors