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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Ovarian Epithelial Cancer Fallopian Tube Cancer Primary Peritoneal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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p53 gene plus chemotherapy

Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv

Group Type EXPERIMENTAL

p53 gene

Intervention Type DRUG

p53 gene will be given intraperitoneally.

Cisplatin

Intervention Type DRUG

150 mg/m\^2 cisplatin will be given intraperitoneally.

Paclitaxel

Intervention Type DRUG

Paclitaxel (175 mg/m2, 3 h) will be given by iv

chemotherapy

Intraperitoneal cisplatin, and paclitaxel iv

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

150 mg/m\^2 cisplatin will be given intraperitoneally.

Paclitaxel

Intervention Type DRUG

Paclitaxel (175 mg/m2, 3 h) will be given by iv

Interventions

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p53 gene

p53 gene will be given intraperitoneally.

Intervention Type DRUG

Cisplatin

150 mg/m\^2 cisplatin will be given intraperitoneally.

Intervention Type DRUG

Paclitaxel

Paclitaxel (175 mg/m2, 3 h) will be given by iv

Intervention Type DRUG

Other Intervention Names

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recombinant adenoviral human p53 gene

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No