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

Fallopian Tube Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02435186
• Other study ID #: rAd-p53-H20150111
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 28, 2015
• Last updated: April 30, 2015
• Start date: June 2015
• Est. completion date: August 2018

Study information

• Verified date: April 2015
• Source: Shenzhen SiBiono GeneTech Co.,Ltd
• Contact: xiuqing Li, MD
• Phone: +86 18940251286
• Email: 2403621353[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Epithelial Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cancer

Intervention

Drug:
• p53 gene
p53 gene will be given intraperitoneally.
• Cisplatin
150 mg/m^2 cisplatin will be given intraperitoneally.
• Paclitaxel
Paclitaxel (175 mg/m2, 3 h) will be given by iv

Locations

Country	Name	City	State
China	xijing hospital in China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen SiBiono GeneTech Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	Objective response rate using RECIST version 1.1 guidance	from starting study treatment to 6 months	No
Primary	progress-free survival	measure the time to progression/death, or to the last tumor assessment	from starting treatment to 2 years after	No
Secondary	overall survival	measure the time to death, or time last known alive	from starting study treatment to 2 years after	No
Secondary	Karnofsky Performance Status score(KPS)		from starting study treatment to 2 years after	No
Secondary	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	Yes