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OXO-PCR-01: Oxford Ovarian Cancer Predict Chemotherapy Response 01

Sponsor
University of Oxford (Other)
Overall Status
Unknown status
CT.gov ID
NCT01770535
Collaborator
(none)
35
Enrollment
1
Location
30.9
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to understand why there are differences between individuals in the way they respond to paclitaxel chemotherapy.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    35 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Single-Centre Prospective Phase 0 Translational Study for Predicting Response of High Grade Serous Ovarian Cancers to Paclitaxel Chemotherapy
    Study Start Date :
    Nov 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2014
    Anticipated Study Completion Date :
    Jun 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between βIII tubulin expression and Mitotic Index (MI) following single agent paclitaxel treatment [Before and 24-hours after paclitaxel treatment]

      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

    Secondary Outcome Measures

    1. Correlation between mitotic index and the magnitude of CA125 response [three weeks after paclitaxel treatment]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Churchill Hospital Oxford United Kingdom

    Sponsors and Collaborators

    • University of Oxford

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT01770535
    Other Study ID Numbers:
    • OXO-PCR-01
    First Posted:
    Jan 17, 2013
    Last Update Posted:
    Jan 17, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by University of Oxford
    Ovarian cancer, paclitaxel
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Jan 17, 2013