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mTOR inhibitor

Everolimus + Letrozole for Ovarian Cancer

Phase 2
Waitlist Available
Research Sponsored by Sinai Hospital of Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have relapse or refractory or persistent epithelial ovarian, fallopian tube, primary peritoneal carcinoma or endometrial cancer. Histologic documentation of the original primary tumor is required via pathology report
Patients are allowed to have received, but are not required to have received, biologic/targeted therapy (e.g., bevacizumab and/or PARP inhibitor) as part of their primary treatment regimen or for management of relapse or refractory or persistent disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, then every 12 weeks while on everolimus and letrozole up to 36 months
Awards & highlights

Study Summary

This trial is testing if the combination of everolimus (Afinitor®) and letrozole is effective in the treatment of women with either recurrent or persistent epithelial ovarian, fallopian tube, primary peritoneal or endometrial cancer.

Who is the study for?
This trial is for post-menopausal women with recurrent or persistent ovarian, fallopian tube, primary peritoneal, or endometrial cancer that's resistant to platinum-based chemotherapy. Participants must have a performance status of ECOG 2 or better and can't have severe medical conditions like unstable heart disease, serious infections, severely impaired lung function, active bleeding disorders, or liver disease.Check my eligibility
What is being tested?
The study tests the effectiveness of combining Everolimus (Afinitor®), an FDA-approved drug for various cancers including advanced kidney and breast cancer among others, with Letrozole in treating women whose ovarian or endometrial cancer has returned despite treatment.See study design
What are the potential side effects?
Everolimus may cause side effects such as mouth ulcers, infections due to immune system suppression, lung problems like coughing and shortness of breath; skin issues; delayed wound healing; and increased cholesterol levels. Letrozole can lead to hot flashes, joint pain/stiffness/arthritis; fatigue; osteoporosis; high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer (ovarian, fallopian tube, peritoneal, or endometrial) has come back or hasn't responded to treatment.
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I may have had targeted therapy for my cancer, but it's not a must.
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I am post-menopausal or have had my ovaries removed.
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I may have had one extra treatment for my cancer if it came back or didn't respond to treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I have been treated with platinum-based chemotherapy for my primary disease.
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My cancer got worse while I was on my first platinum-based chemotherapy.
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My cancer got worse within a year after my last platinum-based chemotherapy.
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My cancer returned after second round of platinum-based treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, then every 12 weeks while on everolimus and letrozole up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, then every 12 weeks while on everolimus and letrozole up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria
Secondary outcome measures
Overall survival of patients treated with the combination of letrozole and everolimus

Trial Design

1Treatment groups
Experimental Treatment
Group I: SingleExperimental Treatment1 Intervention
This is a single arm, non-randomized, open-label study with a combination of everolimus and letrozole once a day dosing . Each cycle would be 28days and patients would be scanned after every 3 cycles for response, until disease progression is documented

Find a Location

Who is running the clinical trial?

Sinai Hospital of BaltimoreLead Sponsor
7 Previous Clinical Trials
391 Total Patients Enrolled

Media Library

Endometrial Cancer Research Study Groups: Single

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for this experiment restricted to those over 45?

"In accordance with the study's enrollment guidelines, participants must be at least 18 years old and no older than 80."

Answered by AI

Are there any additional investigations into the combined effects of everolimus and letrozole?

"Currently, 241 everolimus and letrozole studies are ongoing worldwide. Of those trials, 54 have entered Phase 3 of the clinical trial process. Amongst these sites, Shanghai has the highest concentration with 13459 locations dedicated to studying this particular treatment."

Answered by AI

What are the prerequisites for participating in this clinical trial?

"The current aim of this clinical trial is to enrol 20 participants suffering from carcinoma, ovarian epithelial aged between 18 and 80. To qualify for the study, applicants must exhibit the following prerequisites: a diagnosis of relapse or refractory/persistent epithelial ovarian, fallopian tube or primary peritoneal carcinomia; evidence via pathology report that they have received treatment with a platinum-based chemotherapy regiment containing carboplatin and cisplatin; postmenopausal/post oophorectomy status; an ECOG performance score less than 2; may but are not required to have already had one additional cytotoxic regimen"

Answered by AI

What potential risks does the combination of everolimus and letrozole pose to individuals?

"The safety of everolimus and letrozole have been judged to be a 2 on the 1-3 scale. This is due to evidence showing its security, however no data has proven it effectiveness in Phase 2 trials."

Answered by AI

What maladies are typically managed with a combination of everolimus and letrozole?

"Everolimus and letrozole are often prescribed to address liver transplant rejection, yet they can also be employed in the treatment of kidney transplants, Waldenstrom macroglobulinemia, and tamoxifen."

Answered by AI

Is the recruitment process for this study still open?

"Clinicialtrials.gov confirms that this trial, first posted on June 1st 2014 and revised May 18th 2015, is not actively seeking enrolment at present. However, there are 2,055 other studies with open recruitment presently available to potential patients."

Answered by AI

What is the aggregate number of participants enrolled in this experiment?

"This clinical trial is no longer accepting new participants as it was last updated on May 18th, 2015. However, if you are searching for alternative studies there are currently 1,814 trials enrolling patients with carcinoma ovarian epithelial and 241 ongoing everolimus/letrozole examinations seeking volunteers."

Answered by AI
~2 spots leftby Mar 2025