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Investigator(s):
Elise C. Kohn, M.D. Principal Investigator Phone: 301-402-2726 kohne@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov	Nicole Houston, B.S.N., R.N. Research Nurse Phone: 301-443-6431 houstonnd@mail.nih.gov

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Key Eligibility Criteria:

• ≥ 18 years of age
• Women with a diagnosis of one of the following:
• Epithelial ovarian*, fallopian, or primary peritoneal cancer
• Uterine papillary serous cancer or malignant mixed mullerian tumor
• Cervical cancer
• Any type of breast cancer that is metastatic or unresectable and for whom curative therapies do not exist (previously treated with standard therapy)**
• Men who have metastatic breast cancer and have a BRCA-1/2 mutation
• ECOG 0–2
• No limit to the number of prior treatment regimens
• Able to swallow pills
• Adequate organ function
• Normal coagulation
• At least 6 months since prior platinum drugs
• Patients with platinum-resistant disease are eligible
• No previous treatment with olaparib (AZD2281)

*Ovarian or endometrial cancer patients with deleterious mutation in DNA repair enzymes may be treated in first recurrence independent of platinum-sensitivity history.
**Breast cancer patients with deleterious mutation in DNA repair enzymes with locally advanced or metastatic disease are not required to have had prior therapy for their progressive disease.

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Study Outline:

The dose-escalation phase of the study has been completed.

• Physical examination and medical history; blood and tumor samples; and imaging studies as required
• Study participants will be divided into two groups
• Both groups will receive olaparib tablets by mouth and carboplatin by infusion (through a vein)
• Up to 8 courses of olaparib and carboplatin
• Participants may continue to take olaparib if their cancer responds
• Additional blood and tissue samples and imaging studies will be conducted throughout the treatment period

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 8/24/12
Updated: 2/2/12