p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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 1012 viral particles) plus cisplatin 150 mg/m2, 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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: p53 gene plus chemotherapy Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv |
Drug: p53 gene
p53 gene will be given intraperitoneally.
Other Names:
Drug: Cisplatin
150 mg/m^2 cisplatin will be given intraperitoneally.
Drug: Paclitaxel
Paclitaxel (175 mg/m2, 3 h) will be given by iv
|
Active Comparator: chemotherapy Intraperitoneal cisplatin, and paclitaxel iv |
Drug: Cisplatin
150 mg/m^2 cisplatin will be given intraperitoneally.
Drug: Paclitaxel
Paclitaxel (175 mg/m2, 3 h) will be given by iv
|
Outcome Measures
Primary Outcome Measures
- response rate [from starting study treatment to 6 months]
Objective response rate using RECIST version 1.1 guidance
- progress-free survival [from starting treatment to 2 years after]
measure the time to progression/death, or to the last tumor assessment
Secondary Outcome Measures
- overall survival [from starting study treatment to 2 years after]
measure the time to death, or time last known alive
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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histopathologically diagnosed ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer
-
recurrent
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18 years or older
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with normal tests of hemogram, blood coagulation, liver and kidney function
-
signed the informed consent form.
Exclusion Criteria:
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Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
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have serious heart, lung function abnormalities or severe diabetes patients;
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active infection;
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severe atherosclerosis;
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AIDS patients;
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serious thrombotic or embolic events within 6 months;
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renal insufficiency requiring hemodialysis or peritoneal dialysis;
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pregnant or lactating women;
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mental disorder or disease.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | xijing hospital in China Medical University | Shenyang | Liaoning | China | 110022 |
Sponsors and Collaborators
- Shenzhen SiBiono GeneTech Co.,Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- rAd-p53-H20150111