AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer
Status:
Completed
Trial end date:
2019-10-18
Target enrollment:
Participant gender:
Summary
Background:
- Carboplatin is approved by the Food and Drug Administration to treat cancer.
- AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a
protein that is -involved in repairing DNA damage; PARP inhibitors interfere with that
process.
Objectives:
- To determine the optimum doses of AZD2281 and carboplatin that can safely be used in
patients with breast and ovarian cancer.
- To evaluate the response of the tumor to the drug combination and determine the side
effects of the treatment.
Eligibility:
-Patients 18 years of age or older with breast or ovarian cancer who have a family history of
cancer or who have a BRCA1 or BRCA2 mutation.
Design:
- In this dose escalation study, the first small group of patients receives the smallest
study doses of AZD2281 and carboplatin. Subsequent groups receive incrementally higher
doses of first AZD2281 and then carboplatin as long as the preceding group has not
experienced unacceptable side effects. When the highest safe dose is determined,
additional patients receive that dose.
- Patients receive treatment in 21-day cycles as follows: AZD2281 by mouth twice a day
every day; carboplatin thorough a vein on day 8 of each cycle. Treatment may continue
until it is no longer beneficial.
- Evaluations during treatment include the following:
- Physical examination 1 week after starting treatment and then every 3 weeks.
- Blood tests weekly for the first 4 weeks of treatment and then every 3 weeks.
- CT scans or other imaging tests such as ultrasound or MRI every 6 weeks to evaluate the
tumor.