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

Study Overview
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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.

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).

Official Title
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Recombinant Adenoviral p53 Human Gene Combined With Chemotherapy in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

Conditions
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Ovarian Epithelial Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Intervention / Treatment
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* Drug: p53 gene
* Drug: Cisplatin
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histopathologically diagnosed ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer recurrent 18 years or older with normal tests of hemogram, blood coagulation, liver and kidney function signed the informed consent form. Exclusion Criteria: Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L; have serious heart, lung function abnormalities or severe diabetes patients; active infection; severe atherosclerosis; AIDS patients; serious thrombotic or embolic events within 6 months; renal insufficiency requiring hemodialysis or peritoneal dialysis; pregnant or lactating women; mental disorder or disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: p53 gene plus chemotherapy<br>Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv | Drug: p53 gene<br>* p53 gene will be given intraperitoneally.<br>* Other names: recombinant adenoviral human p53 gene;Drug: Cisplatin<br>* 150 mg/m^2 cisplatin will be given intraperitoneally.<br>Drug: Paclitaxel<br>* Paclitaxel (175 mg/m2, 3 h) will be given by iv<br>|
| Active Comparator: chemotherapy<br>Intraperitoneal cisplatin, and paclitaxel iv | Drug: Cisplatin<br>* 150 mg/m^2 cisplatin will be given intraperitoneally.<br>Drug: Paclitaxel<br>* Paclitaxel (175 mg/m2, 3 h) will be given by iv<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | measure the time to death, or time last known alive | from starting study treatment to 2 years after | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fallopian tube cancer, primary peritoneal cancer, p53 gene, chemotherapy, recurrent, epithelial, ovarian cancer