NCT02283658

Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

A Phase 2 Trial of Letrozole and Everolimus in Relapsed Hormone Receptor Positive Ovarian, Fallopian Tube or Primary Peritoneal Carcinomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot, phase II trial studies how well everolimus and letrozole work in treating patients with hormone receptor positive ovarian, fallopian tube, or primary peritoneal cavity cancer that has come back. Everolimus and letrozole may stop the growth of tumor cells by blocking some the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. Demonstrate that the combination of letrozole and everolimus leads to a higher percentage of patients who are free of progression at 12 weeks (PFS 12) as compared with that observed in a previously reported phase 2 trial of letrozole alone for relapsed ovarian carcinomas. SECONDARY OBJECTIVES: I. Cancer antigen (CA)-125 response, progression-free survival (PFS), overall survival (OS), the confirmed response rate, and adverse events. TERTIARY OBJECTIVES: I. Identify molecular biomarkers associated with a response to treatment with letrozole and everolimus in patients with relapsed ovarian carcinomas. II. Develop and determine if response rates to letrozole and everolimus in patient derived xenograft (PDX) avatars correlate to responses noted in the patients. OUTLINE: Patients receive everolimus orally (PO) once daily (QD) and letrozole PO QD on days 1-28. Courses repeat 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 2 years.

Conditions

• Ovarian Endometrioid Adenocarcinoma
• Ovarian Seromucinous Carcinoma
• Ovarian Serous Cystadenocarcinoma
• Ovarian Serous Surface Papillary Adenocarcinoma
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Ovarian Germ Cell Tumor
• Recurrent Primary Peritoneal Carcinoma
• Undifferentiated Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	Everolimus	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Letrozole	Given PO

Timeline

• Start date: 2014-11-14
• Primary completion: 2016-06-15
• Completion: 2018-06-21
• First posted: 2014-11-05
• Last updated: 2020-10-23
• Results posted: 2020-03-31

Locations

2 sites across 1 country: United States