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

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

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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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Contacts and Locations

Contacts

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

Locations

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

• Study Director: Nan Du, PhD; PLA 304 hospital

More Information

• 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
• Last Update Posted: April 13, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• 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:

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