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Oxford Ovarian Cancer Predict Chemotherapy Response 01 (OXO-PCR-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01770535
Recruitment Status : Unknown
Verified January 2013 by University of Oxford.
Recruitment status was:  Recruiting
First Posted : January 17, 2013
Last Update Posted : January 17, 2013
Information provided by (Responsible Party):
University of Oxford

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
Ovarian Cancer

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 Type : Observational
Estimated 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 : November 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Primary Outcome Measures :
  1. Correlation between βIII tubulin expression and Mitotic Index (MI) following single agent paclitaxel treatment [ Time Frame: 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 [ Time Frame: 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

Biospecimen Retention:   Samples With DNA
Ovarian cancer biopsy tissue samples Eyebrow hair follicles Blood samples Surgical tissue samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01770535

Contact: Ahmed A Ahmed

United Kingdom
Churchill Hospital Recruiting
Oxford, United Kingdom
Principal Investigator: Ahmed A Ahmed         
Sponsors and Collaborators
University of Oxford

Responsible Party: University of Oxford Identifier: NCT01770535     History of Changes
Other Study ID Numbers: OXO-PCR-01
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by University of Oxford:
Ovarian cancer, paclitaxel

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action