Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVES: I. To evaluate the association of BROCA-homologous recombination (HR) with the clinical activity of cediranib maleate (cediranib)/olaparib, as measured by progression-free survival (PFS), in women with recurrent platinum-sensitive ovarian cancer. II. To assess the clinical activi...

PRIMARY OBJECTIVES: I. To evaluate the association of BROCA-homologous recombination (HR) with the clinical activity of cediranib maleate (cediranib)/olaparib, as measured by progression-free survival (PFS), in women with recurrent platinum-sensitive ovarian cancer. II. To assess the clinical activity of cediranib/olaparib, as measured by objective response, in women with recurrent platinum-resistant ovarian cancer. SECONDARY OBJECTIVES: I. To assess overall survival (OS), objective response, and clinical benefit (stable disease [SD] or response >= 16 weeks) in women with platinum-sensitive ovarian cancer, and PFS, OS, and clinical benefit in women with platinum-resistant ovarian cancer. II. To assess the safety of cediranib/olaparib in women with recurrent platinum-sensitive and -resistant ovarian cancer. III. To evaluate the association of circulating endothelial cells at baseline and day 3 with the clinical activity of cediranib/olaparib, as measured by PFS, in women with platinum-sensitive and -resistant ovarian cancer. IV. To evaluate changes in BROCA-HR status between archival and pre-treatment biopsy samples. V. To evaluate the associate of BROCA-HR with the clinical activity of cediranib/olaparib as measured by PFS, in women with platinum-resistant ovarian cancer. VI. To characterize genomic alteration by whole exome sequencing in women with platinum-sensitive and -resistant ovarian cancer. VII. To identify biomarker signatures that correlate with the clinical activity of cediranib/olaparib in women with recurrent platinum-sensitive and -resistant ovarian cancer, including changes in gene expression or acquired mutations in on-treatment tumor biopsies that are associated with clinical activity, and changes in gene expression or acquired mutations in post-progression biopsies that are associated with clinical resistance. VIII. To explore changes in biomarker signatures and candidate angiogenic markers from pre-treatment to post-progression in women with platinum-sensitive and -resistant ovarian cancer. IX. To evaluate the population pharmacokinetics (PK) of the combination of cediranib and olaparib (tablets) in platinum-sensitive and platinum-resistant ovarian cancer. EXPLORATORY OBJECTIVES: I. To determine the feasibility of a mobile phone application (app) ecediranib-olaparib (eCO) to collect patient-generated blood pressure and symptom data based upon study protocol recommendations. II. Assess patient and health care professional perceived usability and satisfaction of the eCO app (for patients) and of a connected web portal (for health care providers). III. Assess the number of generated alerts to the study team (via the web portal and email "high" alerts) based on pre-determined severity levels. OUTLINE: Patients receive olaparib orally (PO) twice daily (BID) and cediranib maleate PO once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

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