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

April 30, 2015 updated by: Shenzhen SiBiono GeneTech Co.,Ltd

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • xijing hospital in China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate
Time Frame: from starting study treatment to 6 months
Objective response rate using RECIST version 1.1 guidance
from starting study treatment to 6 months
progress-free survival
Time Frame: from starting treatment to 2 years after
measure the time to progression/death, or to the last tumor assessment
from starting treatment to 2 years after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: from starting study treatment to 2 years after
measure the time to death, or time last known alive
from starting study treatment to 2 years after
Karnofsky Performance Status score（KPS）
Time Frame: from starting study treatment to 2 years after
from starting study treatment to 2 years after
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
from starting study treatment to 30 days after the last study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen SiBiono GeneTech Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rAd-p53-H20150111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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