Oxford Ovarian Cancer Predict Chemotherapy Response 01

Ovarian Cancer Clinical Trial

— OXO-PCR-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01770535
• Other study ID #: OXO-PCR-01
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2013
• Last updated: January 15, 2013
• Start date: November 2012
• Est. completion date: June 2015

Study information

• Verified date: January 2013
• Source: University of Oxford
• Contact: Ahmed A Ahmed
• Email: ahmed.ahmed[@]obs-gyn.ox.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
United Kingdom	Churchill Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between ßIII tubulin expression and Mitotic Index (MI) following single agent paclitaxel treatment	Correlation between ßIII tubulin expression and Mitotic Index (MI) before and after single agent paclitaxel treatment to determine whether overexpression of ßIII tubulin is associated with Paclitaxel resistance	Before and 24-hours after paclitaxel treatment	No
Secondary	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	No