This is a study that will look at the effects and how useful investigational drug olaparib is as a neoadjuvant treatment (treatment given as to shrink a tumor before the main treatment) prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer.
Olaparib belongs to a class of anti-cancer agents known as poly ADP-ribose polymerase (PARP) inhibitors. Olaparib is a new type of drug for ovarian cancer. Laboratory tests show that it may help slow the growth of ovarian cancer. Olaparib works by blocking the PARP protein. PARP is an important protein which tries to fix damaged deoxyribonucleic acid (DNA, molecules that contain important instructions for the development of cells). Many cancers are thought to develop from damaged DNA. Research has shown that PARP inhibitors stop the PARP protein from working, and that sometimes that can cause cancer cells to stop growing or die.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Chosen by the study doctor, per standard of care.
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal (CHUM
Difference in levels of PAR or PARP-1 before and after study treatment
Time frame: 4-8 weeks
Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue
Time frame: 2.5 years
Frequency of adverse events, by description and grade
Time frame: 2.5 years
Response rate to olaparib in the neoadjuvant period
Time frame: 6 weeks
Duration of progression free survival with olaparib in comparison to platinum based chemotherapy
Time frame: 2.5 years
Levels of ctDNA compared to levels of CA125
Time frame: 2.5 years
Gene expression changes in tumour tissue before and after treatment with Olaparib
Time frame: 2.5 years
Secondary mutation rate in surgical tumour specimens following PARP therapy and at progression
2.5 years
Time frame: 2.5 years
Changes in blood based biomarkers using ctDNA before, during and after treatment with Olaparib
Time frame: 2.5 years
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Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Auckland City Hospital
Grafton, Auckland, New Zealand
Vall d'Hebron University Hospital
Barcelona, Spain
Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom