Clinical trial NCT02435186: p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
Official title: Recombinant Adenoviral p53 Human Gene Combined With Chemotherapy in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Epithelial Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Keywords: p53 gene
chemotherapy
recurrent
epithelial
ovarian cancer
fallopian tube cancer
primary peritoneal cancer
Lead sponsor: Shenzhen SiBiono GeneTech Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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).

Eligibility criteria: Inclusion Criteria:

1. histopathologically diagnosed ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer
2. recurrent
3. 18 years or older
4. with normal tests of hemogram, blood coagulation, liver and kidney function
5. signed the informed consent form.

Exclusion Criteria:

1. Serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/L;
2. have serious heart, lung function abnormalities or severe diabetes patients;
3. active infection;
4. severe atherosclerosis;
5. AIDS patients;
6. serious thrombotic or embolic events within 6 months;
7. renal insufficiency requiring hemodialysis or peritoneal dialysis;
8. pregnant or lactating women;
9. mental disorder or disease.

Primary outcomes:
measure: response rate
timeFrame: from starting study treatment to 6 months
measure: progress-free survival
timeFrame: from starting treatment to 2 years after
Secondary outcomes:
measure: overall survival
timeFrame: from starting study treatment to 2 years after
measure: Karnofsky Performance Status score（KPS）
timeFrame: from starting study treatment to 2 years after
measure: safety as measured by adverse events, vital signs, clinical lab tests, ECG and physical examination
timeFrame: from starting study treatment to 30 days after the last study treatment
Other outcomes:
Locations:
city: Shenyang
country: China
facility: xijing hospital in China Medical University
state: Liaoning
Study officials:
References: