Randomised phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol
<p><strong>Introduction:</strong> Patients relapsing within 12 months of platinum-based chemotherapy usually have a poorer response to subsequent treatments. To date, extensive research into the mechanism of resistance to platinum agents in the treatment of ovarian cancer have not...
| Main Authors: | , , , , , , |
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| Format: | Journal article |
| Language: | English |
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BMJ
2021
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| _version_ | 1826272457144664064 |
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| author | Mansouri, A McGregor, N Dunn, R Dobbie, S Holmes, J Collins, L Nicum, S |
| author_facet | Mansouri, A McGregor, N Dunn, R Dobbie, S Holmes, J Collins, L Nicum, S |
| author_sort | Mansouri, A |
| collection | OXFORD |
| description | <p><strong>Introduction:</strong> Patients relapsing within 12 months of platinum-based chemotherapy usually have a poorer response to subsequent treatments. To date, extensive research into the mechanism of resistance to platinum agents in the treatment of ovarian cancer have not resulted in improved responses or longer survival. Further experimental work and clinical trials with novel agents are therefore justified to address this unmet need.</p>
<p><strong>Methods and Analysis:</strong> Patients with ovarian, fallopian tube, or primary peritoneal cancer that has relapsed within 12 months of platinum-based chemotherapy will be randomised with stratification for BRCA status, prior PARP exposure, and prior anti-angiogenic therapy into weekly paclitaxel (chemotherapy), olaparib, or the combination of cediranib and olaparib. They will be followed until disease progression or unacceptable toxicity develops. Our trial design permits two investigations. We will compare the efficacy and tolerability of single-agent olaparib with weekly paclitaxel. We will also compare the efficacy and tolerability of olaparib with the combination of olaparib and cediranib. The required sample size of 138 participants (46 per arm) was calculated using a 20% one-sided type I error, 80% power, and 15% dropout rate. Recruitment will last 34 months with a follow-up of 18 months.</p>
<p><strong>Ethics and Dissemination:</strong> This study will be conducted under a UK Medicines and Healthcare Products Regulatory Agency (MHRA) Clinical Trials Authorisation (CTA). Approval to conduct the study was obtained from the responsible authority before beginning the study. The sponsor will retain ownership of all data arising from the trial. We aim to publish this research in a specialist peer-reviewed scientific journal on study completion. EudraCT number: 2016-000559-28, Ethics reference number: 16/LO/2150, ISRCTN: ISRCTN14784018, clinicaltrials.gov: NCT03117933</p> |
| first_indexed | 2024-03-06T22:12:53Z |
| format | Journal article |
| id | oxford-uuid:526841ee-0a06-4c00-b7a2-daa5c8c5dd2d |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T22:12:53Z |
| publishDate | 2021 |
| publisher | BMJ |
| record_format | dspace |
| spelling | oxford-uuid:526841ee-0a06-4c00-b7a2-daa5c8c5dd2d2022-03-26T16:25:27ZRandomised phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocolJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:526841ee-0a06-4c00-b7a2-daa5c8c5dd2dEnglishSymplectic ElementsBMJ2021Mansouri, AMcGregor, NDunn, RDobbie, SHolmes, JCollins, LNicum, S<p><strong>Introduction:</strong> Patients relapsing within 12 months of platinum-based chemotherapy usually have a poorer response to subsequent treatments. To date, extensive research into the mechanism of resistance to platinum agents in the treatment of ovarian cancer have not resulted in improved responses or longer survival. Further experimental work and clinical trials with novel agents are therefore justified to address this unmet need.</p> <p><strong>Methods and Analysis:</strong> Patients with ovarian, fallopian tube, or primary peritoneal cancer that has relapsed within 12 months of platinum-based chemotherapy will be randomised with stratification for BRCA status, prior PARP exposure, and prior anti-angiogenic therapy into weekly paclitaxel (chemotherapy), olaparib, or the combination of cediranib and olaparib. They will be followed until disease progression or unacceptable toxicity develops. Our trial design permits two investigations. We will compare the efficacy and tolerability of single-agent olaparib with weekly paclitaxel. We will also compare the efficacy and tolerability of olaparib with the combination of olaparib and cediranib. The required sample size of 138 participants (46 per arm) was calculated using a 20% one-sided type I error, 80% power, and 15% dropout rate. Recruitment will last 34 months with a follow-up of 18 months.</p> <p><strong>Ethics and Dissemination:</strong> This study will be conducted under a UK Medicines and Healthcare Products Regulatory Agency (MHRA) Clinical Trials Authorisation (CTA). Approval to conduct the study was obtained from the responsible authority before beginning the study. The sponsor will retain ownership of all data arising from the trial. We aim to publish this research in a specialist peer-reviewed scientific journal on study completion. EudraCT number: 2016-000559-28, Ethics reference number: 16/LO/2150, ISRCTN: ISRCTN14784018, clinicaltrials.gov: NCT03117933</p> |
| spellingShingle | Mansouri, A McGregor, N Dunn, R Dobbie, S Holmes, J Collins, L Nicum, S Randomised phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol |
| title | Randomised phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol |
| title_full | Randomised phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol |
| title_fullStr | Randomised phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol |
| title_full_unstemmed | Randomised phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol |
| title_short | Randomised phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol |
| title_sort | randomised phase ii trial of olaparib chemotherapy or olaparib and cediranib in patients with platinum resistant ovarian cancer octova a study protocol |
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