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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
p53 gene will be given intraperitoneally.
150 mg/m\^2 cisplatin will be given intraperitoneally.
Paclitaxel (175 mg/m2, 3 h) will be given by iv
xijing hospital in China Medical University
Shenyang, Liaoning, China
response rate
Objective response rate using RECIST version 1.1 guidance
Time frame: from starting study treatment to 6 months
progress-free survival
measure the time to progression/death, or to the last tumor assessment
Time frame: from starting treatment to 2 years after
overall survival
measure the time to death, or time last known alive
Time frame: from starting study treatment to 2 years after
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
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