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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| p53 gene plus chemotherapy | Experimental | Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv |
|
| chemotherapy | Active Comparator | Intraperitoneal cisplatin, and paclitaxel iv |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| p53 gene | Drug | p53 gene will be given intraperitoneally. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiuqing Li, MD | Contact | +86 18940251286 | 2403621353@qq.com | |
| qing yu, MD | Contact | +8618620099810 | qingyu1110@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| xijing hospital in China Medical University | Shenyang | Liaoning | 110022 | China |
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| Cisplatin | Drug | 150 mg/m^2 cisplatin will be given intraperitoneally. |
|
| Paclitaxel | Drug | Paclitaxel (175 mg/m2, 3 h) will be given by iv |
|
| 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 |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| D012008 | Recurrence |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016158 | Genes, p53 |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D016147 | Genes, Tumor Suppressor |
| D052138 | Genes, Neoplasm |
| D005796 | Genes |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D005808 | Genes, Recessive |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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