Trials / Unknown
UnknownNCT02435186
p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
Recombinant Adenoviral p53 Human Gene Combined With Chemotherapy in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | p53 gene | p53 gene will be given intraperitoneally. |
| DRUG | Cisplatin | 150 mg/m\^2 cisplatin will be given intraperitoneally. |
| DRUG | Paclitaxel | Paclitaxel (175 mg/m2, 3 h) will be given by iv |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2015-05-06
- Last updated
- 2015-05-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02435186. Inclusion in this directory is not an endorsement.