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

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: Ovarian Epithelial Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
• Intervention / Treatment: Drug: p53 gene; Drug: Cisplatin; Drug: Paclitaxel

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

• Study Contact: Name: xiuqing Li, MD; Phone Number: +86 18940251286; Email: 2403621353@qq.com
• Study Contact Backup: Name: qing yu, MD; Phone Number: +8618620099810; Email: qingyu1110@163.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110022
      • xijing hospital in China Medical University
      • Contact: xiuqing Li, MD; Phone Number: +86 18940251286; Email: 2403621353@qq.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Objective response rate using RECIST version 1.1 guidance	from starting study treatment to 6 months
progress-free survival	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	measure the time to death, or time last known alive	from starting study treatment to 2 years after
Karnofsky Performance Status score（KPS）		from starting study treatment to 2 years after
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

Collaborators and Investigators

• Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

Study record dates

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: chemotherapy; ovarian cancer; fallopian tube cancer; primary peritoneal cancer; p53 gene; recurrent; epithelial
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Digestive System Neoplasms; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Abdominal Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin
• Other Study ID Numbers: rAd-p53-H20150111