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

Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02435186
Collaborator
(none)
100
1
2
38
2.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 1012 viral particles) plus cisplatin 150 mg/m2, 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Aug 1, 2018
Anticipated Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: p53 gene plus chemotherapy

Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv

Drug: p53 gene
p53 gene will be given intraperitoneally.
Other Names:
  • recombinant adenoviral human p53 gene
  • Drug: Cisplatin
    150 mg/m^2 cisplatin will be given intraperitoneally.

    Drug: Paclitaxel
    Paclitaxel (175 mg/m2, 3 h) will be given by iv

    Active Comparator: chemotherapy

    Intraperitoneal cisplatin, and paclitaxel iv

    Drug: Cisplatin
    150 mg/m^2 cisplatin will be given intraperitoneally.

    Drug: Paclitaxel
    Paclitaxel (175 mg/m2, 3 h) will be given by iv

    Outcome Measures

    Primary Outcome Measures

    1. response rate [from starting study treatment to 6 months]

      Objective response rate using RECIST version 1.1 guidance

    2. progress-free survival [from starting treatment to 2 years after]

      measure the time to progression/death, or to the last tumor assessment

    Secondary Outcome Measures

    1. overall survival [from starting study treatment to 2 years after]

      measure the time to death, or time last known alive

    2. Karnofsky Performance Status score(KPS) [from starting study treatment to 2 years after]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 xijing hospital in China Medical University Shenyang Liaoning China 110022

    Sponsors and Collaborators

    • Shenzhen SiBiono GeneTech Co.,Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shenzhen SiBiono GeneTech Co.,Ltd
    ClinicalTrials.gov Identifier:
    NCT02435186
    Other Study ID Numbers:
    • rAd-p53-H20150111
    First Posted:
    May 6, 2015
    Last Update Posted:
    May 6, 2015
    Last Verified:
    Apr 1, 2015

    Study Results

    No Results Posted as of May 6, 2015