- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770535
Oxford Ovarian Cancer Predict Chemotherapy Response 01 (OXO-PCR-01)
January 15, 2013 updated by: University of Oxford
A Single-Centre Prospective Phase 0 Translational Study for Predicting Response of High Grade Serous Ovarian Cancers to Paclitaxel Chemotherapy
The purpose of the study is to understand why there are differences between individuals in the way they respond to paclitaxel chemotherapy.
Study Overview
Status
Unknown
Conditions
Detailed Description
While paclitaxel is very effective in killing cancer cells in a proportion of patients, some patients don't respond to this treatment.
As with any chemotherapy, paclitaxel is associated with unpleasant side effects.
We are doing this study to try and understand what is happening in cancer cells in different individuals after paclitaxel treatment that make them respond differently to the same treatment.
We hope that this study will enable us to develop a method to identify women who are suitable for this form of treatment.
We also want to understand why some cancer cells don't get killed with paclitaxel.
This information will help us to select treatment to suit an individual patient, and thus improve the outcome of treatment and avoid giving treatment that will not benefit the patient.
Study Type
Observational
Enrollment (Anticipated)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmed A Ahmed
- Email: ahmed.ahmed@obs-gyn.ox.ac.uk
Study Locations
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Oxford, United Kingdom
- Recruiting
- Churchill Hospital
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Principal Investigator:
- Ahmed A Ahmed
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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
Female
Sampling Method
Non-Probability Sample
Study Population
Patients with radiological and histological evidence of advanced ovarian cancer, who would standardly be managed by primary chemotherapy and interval debulking surgery
Description
Inclusion Criteria:
- Female ≥ 18 years of age
- Newly diagnosed and histology confirmed primary high grade serous ovarian cancer, high grade serous fallopian tube cancer and primary peritoneal carcinoma.
- Radiological and laparoscopic confirmation of FIGO stage 3C or 4 ovarian cancer.
- Radiological evidence of omental or peritoneal deposits that are accessible for radiology-guided biopsy.
- At least one lesion on CT scan measuring at least 2 cm in maximum diameter performed in the past 31 days. Slightly older scans may be accepted at the discretion of the CI providing the results are considered to remain clinically relevant.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
- Life expectancy of at least 6 months.
- The patient is willing and able to provide written informed consent and comply with the protocol for the duration of the study, and scheduled visits and examinations.
- Acceptable haematological and biochemical indices
Exclusion Criteria:
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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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between βIII tubulin expression and Mitotic Index (MI) following single agent paclitaxel treatment
Time Frame: Before and 24-hours after paclitaxel treatment
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Correlation between βIII tubulin expression and Mitotic Index (MI) before and after single agent paclitaxel treatment to determine whether overexpression of βIII tubulin is associated with Paclitaxel resistance
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Before and 24-hours after paclitaxel treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between mitotic index and the magnitude of CA125 response
Time Frame: three weeks after paclitaxel treatment
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Correlation between mitotic index and the magnitude of CA125 response will be analysed to investigate whether post-paclitaxel mitotic index is a determinant of clinical response in ovarian cancer
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three weeks after paclitaxel treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2012
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
January 15, 2013
First Submitted That Met QC Criteria
January 15, 2013
First Posted (Estimate)
January 17, 2013
Study Record Updates
Last Update Posted (Estimate)
January 17, 2013
Last Update Submitted That Met QC Criteria
January 15, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- OXO-PCR-01
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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