Testing the Combination of the Study Drugs Cediranib and Olaparib in Recurrent Ovarian Cancer

Primary Peritoneal Carcinoma Clinical Trial

Official title: A Phase 2 Study of Olaparib and Cediranib for the Treatment of Recurrent Ovarian Cancer

Status Active, not recruiting

Clinical Trial Summary

This phase II trial studies how well olaparib and cediranib maleate work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement (recurrent). Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial 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 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 -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 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a biopsy of tumor, blood sample collection, multigated acquisition scan (MUGA) or echocardiogram, and computed tomography (CT) scan or magnetic resonance imaging (MRI) scan throughout the study.

After completion of study treatment, patients are followed up for 30 days. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Endometrioid
• Fallopian Tube Carcinoma
• Fallopian Tube Endometrioid Adenocarcinoma
• Fallopian Tube Serous Adenocarcinoma
• Ovarian Carcinoma
• Primary Peritoneal Carcinoma
• Primary Peritoneal Endometrioid Adenocarcinoma
• Primary Peritoneal Serous Adenocarcinoma

• NCT number: NCT02345265
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 23, 2016
• Completion date: August 9, 2024