Ovarian Cancer Clinical Trial
Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer
Summary
This research study is a way of gaining new knowledge about a drug called olaparib in women who have either: 1)never received a PARP inhibitor before to treat ovarian cancer (group 1) or 2)participants who have received a PARP inhibitor before to treat ovarian cancer, with the exception of olaparib (group 2). PARP inhibitors are drugs tht prevent cancer cells from repairing their DNA. In this research study, we are looking to see how well the drug olaparib works in women who have never received a PARP inhibitor for recurrent ovarian cancer as well as those who have received a prior PARP inhibitor and whose cancer has re-grown after receiving that PARP inhibitor.
Full Description
Olaparib tablets will be taken twice daily, orally, in treatment cycles lasting 4 weeks.
On days 1, 8, 12 and 22 of the first 2 cycles and day 1 of all other cycles, subjects will have a physical exam, be asked questions about their general health, and specific questions about any problems they might be having and any medications they are taking.
Tumor will be assess by either CT or MRI scan every 2 cycles (every 2 months). Tumor biopsies will be optional in this study. Only participants that have received a PARP inhibitor in the past will be asked to have a biopsy of their tumor.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed ovarian, peritoneal or fallopian tube cancer that has recurred following a platinum-based regimen used at initial diagnosis
Measurable disease
Estimated life expectancy greater than 16 weeks
Normal organ and marrow function
Evidence of non-childbearing status for women of childbearing potential
Able to swallow oral medication
Exclusion Criteria:
Pregnant or breastfeeding
Prior PARP inhibitor use for another cancer such as breast cancer
Receiving any other study agents or any other anti-cancer treatment
Known brain metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
History of a different malignancy unless disease-free for at least 5 years
Currently experiencing seizures or currently being treated with any anti-epileptic for seizures
Human immunodeficiency virus (HIV) positive on combination antiretroviral therapy
Presence of gastrointestinal disorders that, in the investigator's opinion, are likely to interfere with the absorption of olaparib, or with the patient's ability to take regular oral medication
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There is 1 Location for this study
Boston Massachusetts, 02215, United States
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