NCT02435186

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 6, 2015

Status Verified

April 1, 2015

Enrollment Period

3.2 years

First QC Date

April 28, 2015

Last Update Submit

April 30, 2015

Conditions

Ovarian Epithelial CancerFallopian Tube CancerPrimary Peritoneal Cancer

Keywords

p53 genechemotherapyrecurrentepithelialovarian cancerfallopian tube cancerprimary peritoneal cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • overall survival

    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

Study Arms (2)

p53 gene plus chemotherapy

EXPERIMENTAL

Intraperitoneal p53 gene plus cisplatin, and paclitaxel iv

Drug: p53 geneDrug: CisplatinDrug: Paclitaxel

chemotherapy

ACTIVE COMPARATOR

Intraperitoneal cisplatin, and paclitaxel iv

Drug: CisplatinDrug: Paclitaxel

Interventions

p53 geneDRUG

p53 gene will be given intraperitoneally.

Also known as: recombinant adenoviral human p53 gene
p53 gene plus chemotherapy
CisplatinDRUG

150 mg/m\^2 cisplatin will be given intraperitoneally.

chemotherapyp53 gene plus chemotherapy
PaclitaxelDRUG

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

chemotherapyp53 gene plus chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histopathologically diagnosed ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer
  • recurrent
  • years or older
  • with normal tests of hemogram, blood coagulation, liver and kidney function
  • signed the informed consent form.

You may not qualify if:

  • 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;
  • renal insufficiency requiring hemodialysis or peritoneal dialysis;
  • pregnant or lactating women;
  • mental disorder or disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

xijing hospital in China Medical University

Shenyang, Liaoning, 110022, China

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube NeoplasmsRecurrenceOvarian Neoplasms

Interventions

Genes, p53CisplatinPaclitaxel

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genes, Tumor SuppressorGenes, NeoplasmGenesGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGenes, RecessiveChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

xiuqing Li, MD

CONTACT

+86 189402512862403621353@qq.com

qing yu, MD

CONTACT

+8618620099810qingyu1110@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 6, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

May 6, 2015

Record last verified: 2015-04

Locations

CN(1)