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

Primary Purpose

Ovarian Epithelial Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
p53 gene
Cisplatin
Paclitaxel
Sponsored by
Shenzhen SiBiono GeneTech Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Epithelial Cancer focused on measuring p53 gene, chemotherapy, recurrent, epithelial, ovarian cancer, fallopian tube cancer, primary peritoneal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • xijing hospital in China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

p53 gene plus chemotherapy

chemotherapy

Arm Description

Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv

Intraperitoneal cisplatin, and paclitaxel iv

Outcomes

Primary Outcome Measures

response rate
Objective response rate using RECIST version 1.1 guidance
progress-free survival
measure the time to progression/death, or to the last tumor assessment

Secondary Outcome Measures

overall survival
measure the time to death, or time last known alive
Karnofsky Performance Status score（KPS）
safety as measured by adverse events, vital signs, clinical lab tests, ECG and physical examination

Full Information

First Posted
April 28, 2015
Last Updated
April 30, 2015
Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02435186
Brief Title
p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
Official Title
Recombinant Adenoviral p53 Human Gene Combined With Chemotherapy in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Epithelial Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Keywords
p53 gene, chemotherapy, recurrent, epithelial, ovarian cancer, fallopian tube cancer, primary peritoneal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
p53 gene plus chemotherapy
Arm Type
Experimental
Arm Description
Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv
Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
Intraperitoneal cisplatin, and paclitaxel iv
Intervention Type
Drug
Intervention Name(s)
p53 gene
Other Intervention Name(s)
recombinant adenoviral human p53 gene
Intervention Description
p53 gene will be given intraperitoneally.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
150 mg/m^2 cisplatin will be given intraperitoneally.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel (175 mg/m2, 3 h) will be given by iv
Primary Outcome Measure Information:
Title
response rate
Description
Objective response rate using RECIST version 1.1 guidance
Time Frame
from starting study treatment to 6 months
Title
progress-free survival
Description
measure the time to progression/death, or to the last tumor assessment
Time Frame
from starting treatment to 2 years after
Secondary Outcome Measure Information:
Title
overall survival
Description
measure the time to death, or time last known alive
Time Frame
from starting study treatment to 2 years after
Title
Karnofsky Performance Status score（KPS）
Time Frame
from starting study treatment to 2 years after
Title
safety as measured by adverse events, vital signs, clinical lab tests, ECG and physical examination
Time Frame
from starting study treatment to 30 days after the last study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histopathologically diagnosed ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer recurrent 18 years or older with normal tests of hemogram, blood coagulation, liver and kidney function signed the informed consent form. Exclusion Criteria: Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L; have serious heart, lung function abnormalities or severe diabetes patients; active infection; severe atherosclerosis; AIDS patients; serious thrombotic or embolic events within 6 months; renal insufficiency requiring hemodialysis or peritoneal dialysis; pregnant or lactating women; mental disorder or disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiuqing Li, MD
Phone
+86 18940251286
Email
2403621353@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
qing yu, MD
Phone
+8618620099810
Email
qingyu1110@163.com
Facility Information:
Facility Name
xijing hospital in China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110022
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiuqing Li, MD
Phone
+86 18940251286
Email
2403621353@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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