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Phase II randomized study of olaparib, chemotherapy, or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol.

At G.O. Institute we are always reviewing up and coming treatment options.  This is a study to keep tabs on since it will help determine if an oral combination of PARP inhibitor and an oral version of a biological that acts like bevacizumab (anti-angiogenic) has a role in the treatment of specifically recurrent platinum-resistant ovarian cancer.

Phase II randomized study of olaparib, chemotherapy, or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol.

BMJ Open. 2021, January 15; 11 (1): e041463

Authors: Mansouri A., McGregor N., Dunn R., Dobbie S., Holmes J., Collins L., Nicum S.

abstract
INTRODUCTION: Patients who relapse within 12 months of platinum-based chemotherapy tend to have poorer response to subsequent treatments. So far, extensive studies of the mechanism of resistance to platinum drugs in the treatment of ovarian cancer have not led to improved responses or longer survival. Further experimental work and clinical studies with novel active ingredients are therefore justified in order to meet this unmet need. Patients with ovarian, fallopian tube, or primary peritoneal cancer who have relapsed within 12 months of platinum-based chemotherapy will be randomized to stratification for the BReast CAncer gene (BRCA) status, prior exposure to poly (ADP- Ribose) polymerase (PARP) and previous antiangiogenic therapy with weekly paclitaxel (chemotherapy), olaparib or the combination of cediranib and olaparib. They will be followed until disease progression or unacceptable toxicity develops. Our experimental setup allows two investigations. We will compare the efficacy and safety of olaparib as a single agent with weekly paclitaxel. We will also compare the efficacy and safety of olaparib with the combination of olaparib and cediranib. The required sample size of 138 participants (46 per arm) was calculated using a one-sided Type I error of 20%, an achievement of 80%, and a dropout rate of 15%. Recruitment takes 34 months with a follow-up period of 18 months.
METHODS AND ANALYSIS: ETHICS AND DISTRIBUTION: This study is being conducted under the approval of the UK Medicines and Health Products Regulatory Agency for clinical trials. Approval to conduct the study was obtained from the competent authority prior to the start of the study. The sponsor retains ownership of all data resulting from the test version. We aim to publish this research in a peer-reviewed journal upon completion of the study. EudraCT number: 2016-000559-28, Ethics reference number: 16 / LO / 2150.
TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN14784018, clinicaltrials.gov: NCT03117933; Preliminary results.

PMID: 33452192 [PubMed – as supplied by publisher]

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Dr Steve Vasilev MD
“I help and guide women to defeat gynecologic cancers and advanced pelvic conditions such as endometriosis, using a unique combination of minimally invasive robotic surgery, precision medicine therapies and complementary holistic natural support towards thriving in survivorship." Dr. Vasilev is the only physician quadruple board certified in Ob-Gyn, Gynecologic Oncology and Integrative & Holistic Medicine in the United States. He is an accomplished advanced robotic surgeon and serves as Medical Director of Integrative Medicine and Integrative Gynecologic Oncology at Providence Saint John's Health Center, Professor at John Wayne Cancer Institute in Santa Monica, California and is Clinical Professor at Loma Linda University School of Medicine. He is former faculty and professor at UC Irvine, UCLA, USC and City of Hope. He is an active member of multiple medical societies and has been nationally listed in "Best Doctors" for 18 years.

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