Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, Peritoneal Cancer, or Recurrent Triple-Negative Breast Cancer

OBJECTIVES:

Primary

- Assess the maximum-tolerated dose of cediranib maleate in combination with olaparib in
patients with recurrent platinum-sensitive papillary-serous ovarian, fallopian tube, or
peritoneal cancer or metastatic triple-negative breast cancer. (Phase I)

- Assess the efficacy, in terms of progression-free survival (PFS), of cediranib maleate
with versus without olaparib in patients with recurrent grade 2 or 3 platinum-sensitive
papillary-serous ovarian, fallopian tube, or peritoneal cancer. (Phase II)

Secondary

- Assess the toxicity of this regimen in these patients. (Phase I)

- Assess the clinical benefit, PFS, and overall survival of patients treated with this
regimen. (Phase I)

- Assess tumor response, clinical response benefit, and overall survival of patients
treated with these regimens. (Phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a randomized
phase II study.

- Phase I: Patients receive oral cediranib maleate once daily and oral olaparib twice
daily on days 1-28. Treatment repeats every 28 days in the absence of disease
progression or unacceptable toxicity.

- Phase II: Patients are stratified according to prior antiangiogenic therapy (yes vs no)
and BRCA mutation status (carrier vs non-carrier vs unknown). Patients are randomized
to 1 of 2 treatment arms.

- Arm I: Patients receive oral cediranib maleate once daily on days 1-28.

- Arm II: Patients receive oral cediranib maleate once daily and oral olaparib twice
daily on days 1-28.

In both arms, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years.