A Single-Centre Prospective Phase 0 Translational Study for Predicting Response of High Grade Serous Ovarian Cancers to Paclitaxel Chemotherapy
18 Years
N/A
Female
Ovarian Cancer
Trial Information
A Single-Centre Prospective Phase 0 Translational Study for Predicting Response of High Grade Serous Ovarian Cancers to Paclitaxel Chemotherapy
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.
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:
-
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Correlation between βIII tubulin expression and Mitotic Index (MI) following single agent paclitaxel treatment
Outcome Description:
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
Outcome Time Frame:
Before and 24-hours after paclitaxel treatment
Safety Issue:
No
Authority:
United Kingdom: Research Ethics Committee
Study ID:
OXO-PCR-01
NCT ID:
NCT01770535
Start Date:
November 2012
Completion Date:
June 2015
Related Keywords:
- Ovarian Cancer
- Ovarian cancer, paclitaxel
- Ovarian Neoplasms
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