Ovarian Epithelial CancerPhase 2NCT02435186
p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
A Phase 2 study testing p53 gene, Cisplatin and Paclitaxel in people with Ovarian Epithelial Cancer and Fallopian Tube Cancer, run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Epithelial Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- p53 gene, Cisplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- renal insufficiency requiring hemodialysis or peritoneal dialysis;
- pregnant or lactating women;
- mental disorder or disease.
Trial locations and contacts
1 site in 1 country.
China1 site
xijing hospital in China Medical University
Shenyang, Liaoning, 110022
xiuqing Li, MD, +86 18940251286, 2403621353@qq.com
About this study
Official title: 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.
Read the 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).
- Being tested
- p53 gene, Cisplatin, Paclitaxel
- Keywords
- p53 gene, chemotherapy, recurrent, epithelial, ovarian cancer, fallopian tube cancer, primary peritoneal cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Recurrence, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
p53 geneDrug
Also called recombinant adenoviral human p53 gene
p53 gene will be given intraperitoneally.
CisplatinDrug
150 mg/m^2 cisplatin will be given intraperitoneally.
PaclitaxelDrug
Paclitaxel (175 mg/m2, 3 h) will be given by iv
| Study group | Role | What they receive |
|---|---|---|
| p53 gene plus chemotherapy | Experimental | Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv Receives: Drug: p53 gene; Drug: Cisplatin; Drug: Paclitaxel |
| chemotherapy | Active comparator | Intraperitoneal cisplatin, and paclitaxel iv Receives: Drug: Cisplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Objective response rate using RECIST version 1.1 guidance
Measured: from starting study treatment to 6 months
progress-free survival
measure the time to progression/death, or to the last tumor assessment
Measured: from starting treatment to 2 years after
Secondary outcomes (3)
overall survival
measure the time to death, or time last known alive
Measured: from starting study treatment to 2 years after
Karnofsky Performance Status score（KPS）
Measured: from starting study treatment to 2 years after
safety as measured by adverse events, vital signs, clinical lab tests, ECG and physical examination
Measured: from starting study treatment to 30 days after the last study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Epithelial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435186
- Sponsor's protocol ID
- rAd-p53-H20150111
- Status last verified
- Apr 2015
- First submitted
- 28 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Adenoviral p53 Human Gene Combined With Chemotherapy in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT02435186
- Acronym / sponsor ID
- rAd-p53-H20150111
- Keywords
- p53 gene, chemotherapy, recurrent, epithelial, ovarian cancer, fallopian tube cancer, primary peritoneal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| p53 gene plus chemotherapy | Experimental | Drug: p53 gene, Drug: Cisplatin, Drug: PaclitaxelIntraperitoneal p53 gene plus cisplatin, and paclitaxel iv |
| chemotherapy | Active comparator | Drug: Cisplatin, Drug: PaclitaxelIntraperitoneal cisplatin, and paclitaxel iv |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| p53 geneAlso: recombinant adenoviral human p53 genep53 gene will be given intraperitoneally. | Drug | p53 gene plus chemotherapy |
| Cisplatin150 mg/m^2 cisplatin will be given intraperitoneally. | Drug | chemotherapy, p53 gene plus chemotherapy |
| PaclitaxelPaclitaxel (175 mg/m2, 3 h) will be given by iv | Drug | chemotherapy, p53 gene plus chemotherapy |
Primary outcome
response rate
Time frame: from starting study treatment to 6 months
Objective response rate using RECIST version 1.1 guidance
progress-free survival
Time frame: from starting treatment to 2 years after
measure the time to progression/death, or to the last tumor assessment
3 secondary outcomes
overall survival
Time frame: from starting study treatment to 2 years after
Karnofsky Performance Status score（KPS）
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing p53 gene, Cisplatin and Paclitaxel in people with Ovarian Epithelial Cancer and Fallopian Tube Cancer, run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiuqing Li, MD (+86 18940251286, 2403621353@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: from starting study treatment to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.