Olaparib in Combination With Carboplatin for Refractory or Recurrent Women s Cancers
Status:
Completed
Trial end date:
2019-12-12
Target enrollment:
Participant gender:
Summary
Background:
- Olaparib is an experimental anti-cancer drug that is part of a class of drugs called PARP
inhibitors. PARP is a protein that is involved in repairing DNA damage, but it may also
encourage precancerous cells to develop into cancer cells. Olaparib has been given safely in
combination with carboplatin, a drug used to treat breast, ovarian, uterine, and cervical
cancer, but more research is needed to determine whether the drugs are more effective when
given together or which drug should be given first.
Objectives:
- To determine the safety and effectiveness of combined carboplatin and olaparib as a
treatment for gynecologic (female organ) or breast cancer.
Eligibility:
- Women at least 18 years of age who have breast, ovarian, uterine, or cervical cancer
that has not responded to standard treatments.
- Men at least 18 years of age who have metastatic breast cancer and have a BRCA-1/2
mutation.
Design:
- Participants will be screened with a physical examination and medical history, as well
as blood and tumor samples and imaging studies as required by the researchers. Study
participants will then be divided into two groups.
- Group 1: Participants will receive olaparib tablets twice a day for 7 days (14 doses)
and will receive carboplatin by vein on day 1 or 2, for a 21-day treatment cycle. Group
1 study is designed to determine the safety of new tablet formulation of olaparib.
- Group 2: Participants will be divided into two smaller groups, with reversed treatment
schedules. Group 2 study is designed to evaluate which drug should be given first
through endpoint studies in blood samples.
- Group 2A: Participants will receive olaparib tablets twice a day for 7 days (14 doses)
and then carboplatin on day 8 of the first cycle. Cycle 2 will start with carboplatin on
day 1 and olaparib starting on day 2 for 7 days (14 doses).
- Group 2B: Participants will receive carboplatin on the first day of the first cycle, and
then olaparib on day 2, twice a day for 7 days (14 doses) of the first cycle. Cycle 2
will start with 7 days of olaparib (14 doses) and carboplatin will be given on day 8.
- From cycle 3 until completion of therapy, all Group 2 participants will follow the
schedule used for Group 1 (carboplatin on day 1 or 2 of the week of olaparib therapy,
also in 21-day cycles).
- Additional blood and tissue samples and imaging studies will be conducted throughout the
treatment period.
- All participants may receive no more than 8 cycles of olaparib and carboplatin therapy,
but may continue to take olaparib if their cancer responds to the treatment.