Clinical trial NCT01770535: Oxford Ovarian Cancer Predict Chemotherapy Response 01
Official title: A Single-Centre Prospective Phase 0 Translational Study for Predicting Response of High Grade Serous Ovarian Cancers to Paclitaxel Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Keywords: Ovarian cancer, paclitaxel
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Correlation between βIII tubulin expression and Mitotic Index (MI) following single agent paclitaxel treatment
timeFrame: Before and 24-hours after paclitaxel treatment
Secondary outcomes:
measure: Correlation between mitotic index and the magnitude of CA125 response
timeFrame: three weeks after paclitaxel treatment
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
References: