Oxford Ovarian Cancer Predict Chemotherapy Response 01

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

Detailed Description
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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.

Official Title
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A Single-Centre Prospective Phase 0 Translational Study for Predicting Response of High Grade Serous Ovarian Cancers to Paclitaxel Chemotherapy

Conditions
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Ovarian Cancer

Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between βIII tubulin expression and Mitotic Index (MI) following single agent 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 | Before and 24-hours after paclitaxel treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between mitotic index and the magnitude of CA125 response | 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 | three weeks after paclitaxel treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer, paclitaxel