OCTOVA
Research type
Research Study
Full title
Randomised phase II Trial of olaparib, chemotherapy or olaparib and cediranib in patients with platinum–resistant ovarian cancer
IRAS ID
201093
Contact name
Shibani Nicum
Contact email
Sponsor organisation
University of Oxford
Eudract number
2016-000559-28
ISRCTN Number
ISRCTN14784018
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 10 months, 0 days
Research summary
Research summary
Ovarian cancer is the fifth commonest cancer in UK and represents the commonest cause of death from gynaecologic malignancy and the fourth commonest cause of death from cancer in women. The initial benefit from chemotherapy is usually high for those women with the commonest type of ovarian cancer, but around 20% of women will develop recurrent cancer within 6 months of previous therapy. Ultimately patients with relapsed ovarian cancer will develop disease that becomes resistant to standard therapy and this group are described as having platinum-resistant disease and will have a poor response to subsequent treatments. Extensive research in the mechanism of resistance to platinum agents in the treatment of ovarian cancer so far has not produced any results in terms of improved responses and longer survival. Further experimental work and clinical trials with novel agents are therefore highly justified and address an unmet need. In such a patient population it is important to determine if current targeted treatments, offer an efficacious alternative to chemotherapy in an effort to improve survival and reduce toxicity.
Lay summary of study results:
We wish to thank all the patients who participated and their families for their support of the OCTOVA trial.
Treatment for women diagnosed with ovarian cancer usually involves surgery and platinum chemotherapy. Unfortunately many will develop recurrences of their cancer and will require further treatment and the usual platinum drugs used to treat ovarian cancer, such as cisplatin or carboplatin can stop working. The OCTOVA trial aimed to find out if two new drugs, olaparib and cediranib would be more successful than standard chemotherapy in treating women with relapsed ovarian cancer that could no longer be controlled with platinum.
Olaparib and cediranib are targeted treatments (or biological therapies) that work in different ways. Olaparib is a poly-ADP ribose polymerase (PARP) inhibitor. PARP is a protein found in our cells and it helps damaged cells to repair themselves, and by stopping PARP from working, we hope that cancer cells will not be able to repair themselves and die. Cediranib, is a tyrosine kinase inhibitor, and works by preventing cancers from being able to make the new blood vessels that they need to grow. Researchers know from previous studies that olaparib alone or together with cediranib can help stop ovarian cancers from growing.
The OCTOVA trial compared the effectiveness of using olaparib alone with either the combination of olaparib and cediranib or standard chemotherapy (paclitaxel given weekly) and also assessed if the targeted treatments caused fewer side effects and improved quality of life due to having fewer hospital treatment visits. The trial was funded by AstraZeneca and supported by Cancer Research UK and ran in the UK between 30 May 2017 and 10 January 2020. The researchers recruited 139 women to take part in the study. OCTOVA was a randomised study, and participants received 1 of 3 treatments: Arm A: paclitaxel, Arm B: olaparib or Arm C: olaparib and cediranib.
Paclitaxel is given as a drip into the vein, and was given weekly (day 1, day 8 and day 15), in 4 week cycles. Olaparib and cediranib are tablets that are taken every day. Olaparib is taken twice a day and cediranib once a day. Treatment was given for as long as it was helping the patients, and providing they were able to manage any side effects. Patients in the paclitaxel arm whose cancer got worse also had the option to receive olaparib.
The results of the OCTOVA trial showed that there was no difference in activity between olaparib and weekly paclitaxel. In the group of women who carried the BRCA1 gene mutation, a gene that raises your cancer risk if it becomes altered, olaparib could be considered instead of weekly chemotherapy as the side effects didn’t worsen quality of life and olaparib could be taken as a tablet at home rather than having to come to hospital weekly to have chemotherapy via a drip in the vein. The trial also showed that the combination of olaparib and cediranib was active in this group of women and therefore this combination of tablets could also be considered as another treatment option for patients with relapsed ovarian cancer.
Acknowledging the trial funding from AstraZeneca and support (endorsement) by Cancer Research UK.
The full results of what the researchers found will be available on ClinicalTrials.gov reference number NCT03117933.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/2150
Date of REC Opinion
25 Jan 2017
REC opinion
Further Information Favourable Opinion