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

Phase 2

• Conditions: Ovarian Epithelial Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
• Interventions: Drug: p53 gene; Drug: Cisplatin; Drug: Paclitaxel

• Registration Number: NCT02435186
• Lead Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

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).

Study Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-04-30
• Last Update Submitted: 2015-04-30
• Study First Posted: 2015-05-06
• Last Update Posted: 2015-05-06
• Study Start: 2015-06
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
p53 gene plus chemotherapy	p53 gene	Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv
chemotherapy	Cisplatin	Intraperitoneal cisplatin, and paclitaxel iv
p53 gene plus chemotherapy	Cisplatin	Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv
p53 gene plus chemotherapy	Paclitaxel	Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv
chemotherapy	Paclitaxel	Intraperitoneal cisplatin, and paclitaxel iv

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

xijing hospital in China Medical University; 🇨🇳 Shenyang, Liaoning, China