Fallopian Tube Cancer, Ovarian Epithelial Cancer, Primary Peritoneal Cancer
Conditions
Keywords
p53 gene, chemotherapy, recurrent, epithelial, ovarian cancer, fallopian tube cancer, primary peritoneal cancer
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.
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).
Interventions
DRUGp53 gene
p53 gene will be given intraperitoneally.
DRUGCisplatin
150 mg/m\^2 cisplatin will be given intraperitoneally.
DRUGPaclitaxel
Paclitaxel (175 mg/m2, 3 h) will be given by iv
Sponsors
Shenzhen SiBiono GeneTech Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
Primary Contactxiuqing Li, MD
Backup Contactqing yu, MD
Outcome results
None listed