Clinical Trial: p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Recombinant Adenoviral p53 Human Gene Combined With Chemotherapy in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

Brief Summary: The study objective is to investigate the efficacy and safety of p53 combined with chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer.

Detailed Summary:

The study objective is to investigate the efficacy and safety of p53 combined with chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer.

study design: open-labeled, active controlled, randomized, phase 2 treatments: experiment group will consist of intraperitoneal p53 (2 x 10^12 viral particles) plus cisplatin 150 mg/m^2, and Paclitaxel 175 mg/m^2 IV over 3 h on day 1; every 21 d for 6 cycles.

study end points: response rate, progression-free survival, overall survival and Karnofsky score（KPS).


Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

Current Primary Outcome:

  • response rate [ Time Frame: from starting study treatment to 6 months ]
    Objective response rate using RECIST version 1.1 guidance
  • progress-free survival [ Time Frame: from starting treatment to 2 years after ]
    measure the time to progression/death, or to the last tumor assessment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • overall survival [ Time Frame: from starting study treatment to 2 years after ]
    measure the time to death, or time last known alive
  • Karnofsky Performance Status score（KPS） [ Time Frame: from starting study treatment to 2 years after ]
  • safety as measured by adverse events, vital signs, clinical lab tests, ECG and physical examination [ Time Frame: from starting study treatment to 30 days after the last study treatment ]


Original Secondary Outcome: Same as current

Information By: Shenzhen SiBiono GeneTech Co.,Ltd

Dates:
Date Received: April 28, 2015
Date Started: June 2015
Date Completion: August 2018
Last Updated: April 30, 2015
Last Verified: April 2015