A Phase I Study With an Expansion Cohort of the PARP Inhibitor AZD2281 (KU-0059436) Combined With Carboplatin in Breast and Ovarian Cancer in BRCA1/2 Mutation Carriers (Familial Breast and Ovarian Cancer) and Sporadic Triple Negative Breast Cancer and Ovarian Cancer

Detailed 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.

Study Details

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