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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Mayo Clinic

Current Primary Outcome: Proportion of patients alive and PFS12 [ Time Frame: 12 weeks ]

The proportion of PFS12 successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact binomial method.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • CA-125 response, defined as a 50% or greater reduction in baseline CA-125 [ Time Frame: Up to 2 years ]
    The treatment of letrozole and everolimus will be considered promising, based on CA-125, if the observed CA-125 response rate is 30% or more.
  • Confirmed response rate, estimated using RECIST 1.1 criteria [ Time Frame: Up to 24 weeks ]
    A confirmed tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.
  • Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days post-treatment ]
    The maximum grade for each type of adverse event (AE) will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns.
  • OS [ Time Frame: Time from registration to death from any cause, assessed up to 2 years ]
    OS will be estimated using the method of Kaplan-Meier.
  • PFS [ Time Frame: Time from registration to the first of either disease progression or death from any cause, assessed up to 2 years ]
    PFS will be estimated using the method of Kaplan-Meier.


Original Secondary Outcome:

  • CA-125 response, defined as a 50% or greater reduction in baseline CA-125 [ Time Frame: Up to 2 years ]
    The treatment of letrozole and everolimus will be considered promising, based on CA-125, if the observed CA-125 response rate is 30% or more.
  • PFS [ Time Frame: Time from registration to the first of either disease progression or death from any cause, assessed up to 2 years ]
    PFS will be estimated using the method of Kaplan-Meier.
  • OS [ Time Frame: Time from registration to death from any cause, assessed up to 2 years ]
    OS will be estimated using the method of Kaplan-Meier.
  • Confirmed response rate, estimated using RECIST 1.1 criteria [ Time Frame: Up to 24 weeks ]
    A confirmed tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.
  • Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days post-treatment ]
    The maximum grade for each type of adverse event (AE) will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns.


Information By: Mayo Clinic

Dates:
Date Received: November 3, 2014
Date Started: November 2014
Date Completion: November 2017
Last Updated: March 21, 2017
Last Verified: March 2017