Sponsor: University of Oxford
A Single-Centre Prospective Phase 0 Translational Study for Predicting Response of High Grade Serous Ovarian Cancers to Paclitaxel Chemotherapy
Aim and Design
There are two study groups -
- All patients who give consent to the trial enter the Tumour Mapping Group. Patients have a biopsy taken by key-hole surgery to test their ovarian cancer. Patients then have the treatment which is standard care for their cancer (chemotherapy with paclitaxel and carboplatin followed by surgery). The patient donates a second set of samples during the surgery so their tumours can be compared before and after chemotherapy. This will allow the researchers to see how the chemotherapy has affected their tumours.
- In addition to the Tumour Mapping Group, if a patient gives consent they can enter the Single-Dose Group. After the key-hole biopsy, but before starting standard chemotherapy, patients have some extra scans and procedures and then receive an additional dose of paclitaxel. More samples are taken before and after the single dose of paclitaxel allowing the researchers to see how the paclitaxel has affected the cancer under closely controlled conditions. Patients then go on to receive the standard chemotherapy and donate additional samples at standard surgery as in the Tumour Mapping Group.
OXO-PCR-01 is a single centre study at the Churchill Hospital which is currently open to recruitment. Recruitment to the trial is expected to continue until February 2016.
- Female ≥ 18 years of age
- Newly diagnosed and histology confirmed primary high grade serous ovarian cancer , high grade serous fallopian tube cancer or 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 (single-dose group only)
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
- Adequate haematological, hepatic and renal function
- Life expectancy ≥ 6 months.
- Pregnant or breast-feeding women
- Patients with borderline ovarian tumours
- History of previous chemotherapy or radiotherapy to the abdomen or pelvis, for ovarian cancer, or ongoing cancer treatment
- Patients with medical conditions which make them unfit to receive Paclitaxel treatment and/or standard chemotherapy
- Major systemic co-morbidities preventing safe participation
- Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to enrolment
- Other active malignancy requiring treatment or preventing read out from this study
- Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV
- History of previous serious allergic reaction to paclitaxel
- Symptomatic peripheral neuropathy if more than grade 1 in severity
Tumour mapping group:
- To assess tumour response to standard chemotherapy treatment
Single Dose Group:
- To investigate the association between overexpression of βIIIâtubulin and paclitaxel resistance
- To investigate whether post-paclitaxel Mitotic Index (MI) is a determinant of paclitaxel response in ovarian cancer
- To investigate whether early tumour response evidenced by positron emission tomography (PET) and computerised tomography (CT) correlates with overall tumour response to neoadjuvant chemotherapy
Data submission for this trial is via electronic submission of data in OpenClinica.