Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 533 for:    "Primary Peritoneal Carcinoma"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435186
Recruitment Status : Unknown
Verified April 2015 by Shenzhen SiBiono GeneTech Co.,Ltd.
Recruitment status was:  Not yet recruiting
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Shenzhen SiBiono GeneTech Co.,Ltd

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
Ovarian Epithelial Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Drug: p53 gene Drug: Cisplatin Drug: Paclitaxel 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 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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018


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 Name: 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




Primary Outcome Measures :
  1. response rate [ Time Frame: from starting study treatment to 6 months ]
    Objective response rate using RECIST version 1.1 guidance

  2. progress-free survival [ Time Frame: 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 [ Time Frame: from starting study treatment to 2 years after ]
    measure the time to death, or time last known alive

  2. Karnofsky Performance Status score(KPS) [ Time Frame: from starting study treatment to 2 years after ]
  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435186


Contacts
Layout table for location contacts
Contact: xiuqing Li, MD +86 18940251286 2403621353@qq.com
Contact: qing yu, MD +8618620099810 qingyu1110@163.com

Locations
Layout table for location information
China, Liaoning
xijing hospital in China Medical University Not yet recruiting
Shenyang, Liaoning, China, 110022
Contact: xiuqing Li, MD    +86 18940251286    2403621353@qq.com   
Sponsors and Collaborators
Shenzhen SiBiono GeneTech Co.,Ltd

Layout table for additonal information
Responsible Party: Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier: NCT02435186     History of Changes
Other Study ID Numbers: rAd-p53-H20150111
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: April 2015
Keywords provided by Shenzhen SiBiono GeneTech Co.,Ltd:
p53 gene
chemotherapy
recurrent
epithelial
ovarian cancer
fallopian tube cancer
primary peritoneal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators