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

SiBiono

Status and phase: Unknown; Phase 2

Conditions: Primary Peritoneal Cancer; Ovarian Epithelial Cancer; Fallopian Tube Cancer

Treatments: Drug: p53 gene; Drug: Cisplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02435186

rAd-p53-H20150111

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

p53 gene plus chemotherapy

Experimental group

Description:

Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv

Treatment:

Drug: Paclitaxel

Drug: Cisplatin

Drug: p53 gene

chemotherapy

Active Comparator group

Description:

Intraperitoneal cisplatin, and paclitaxel iv

Treatment:

Drug: Paclitaxel

Drug: Cisplatin