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

Sponsor
Chinese PLA General Hospital
Study ID
NCT03095001
Phase
PHASE2
Status
Unknown

Conditions

  • Peritoneal Adhesion

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles
  • Carboplatin — DRUG
    carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles
  • paclitaxel — DRUG
    paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles

Study Details

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.

Key Dates

First listed
Mar 29, 2017
Start date
Jun 1, 2017
Status verified
Apr 2017
Primary completion
Jun 1, 2020
Completion
Jun 1, 2020

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Peritoneal adhesion ORR (pORR) [ Time Frame: 3weeks after the last treatment ]

Central Contacts