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About
The main purpose of this study is to evaluate the effectiveness of the combination of the drugs Everolimus and Letrozole compared to Tamoxifen and Medroxyprogesterone acetate in treating endometrial cancer and to determine the types and severity of side effects caused by treatment with these drug combinations.
Enrollment
Sex
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Volunteers
Inclusion criteria
Note: No prior chemotherapy in the setting of Stage IV disease is permitted unless the patient was without evidence of disease at the completion of chemotherapy and had at least six months of progression-free survival since the completion of chemotherapy.
Regardless of circumstances, no more than one prior chemotherapy regimen (including chemo-radiotherapy) is permitted.
NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN
Bone marrow function:
Coagulation
• INR less than or equal to 1.5 x ULN (or in range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin).
Renal function:
• Creatinine less than or equal to 1.5 x ULN
Hepatic function:
Lipid panel:
At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: hysterectomy, resection of a lung nodule; minor: central venous access catheter placement).
At least 4 weeks must have elapsed since the patient received any radiation therapy.
Patients who have met the pre-entry requirements specified in Section 7.0
Patients must have signed an approved informed consent and authorization permitting release of personal health information.
All patients must be at least 18 years of age
Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing a highly effective form of contraception.
During the study treatment and for 8 weeks after stopping the treatment. Highly effective contraception methods include combination of any two of the following:
Exclusion criteria
Patients who have previously received everolimus, any another mTOR inhibitor or any agent targeting the PI3K/AKT/mTOR pathway.
Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus)
Patients who have previously received hormonal therapy for endometrial cancer.
Patients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.
Patients receiving chronic treatment with systemic steroids or another immunosuppressive agent.
Patients with active or uncontrolled systemic infection.
Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and anti-diabetic treatment must be monitored closely throughout the trial and adjusted as necessary.
Known severely impaired lung function, including:
• CTCAE grade 2 (or greater) hypoxia (decreased oxygen saturation with exercise [e.g., pulse oximeter <88%]; intermittent supplemental oxygen)
Patients with a known history of cardiac disease. This includes:
Uncontrolled hypertension, defined as systolic greater than 150 mm Hg or diastolic greater than 90 mm Hg despite antihypertensive medications.
Myocardial infarction or unstable angina within 6 months prior to registration.
New York Heart Association (NYHA) Class II or greater congestive heart failure.
History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication. This does not include asymptomatic atrial fibrillation with controlled ventricular rate.
Cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months prior to the first date of study therapy.
Patients who are pregnant or breast-feeding.
Patients with known central nervous system metastases.
Patients with known human immunodeficiency virus (HIV) infection.
Patients with an impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease; uncontrolled nausea, vomiting and/or diarrhea; malabsorption syndrome; clinical signs and symptoms of gastrointestinal obstruction; and/or patients who require parenteral hydration and/or nutrition).
Patients who plan to receive live attenuated vaccines within 1 week of start of everolimus and during the study. Patient should also avoid close contact with others who have received live attenuated vaccines. Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines.
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder or coagulopathy.
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days prior to dosing.
Patients must be able to follow concomitant medication restrictions:
Patients with active hepatitis B or C. Screening for hepatitis B
Prior to randomization/start of everolimus, the following three categories of patients should be tested for hepatitis B viral load and serologic markers, that is, HBsAg, HBcAb, HBsAb and quantitative hepatitis B DNA PCR (HBV-DNA):
• All patients who currently live in (or have lived in) Asia, Africa, Central and South America, Eastern Europe, Spain, Portugal and Greece.
[http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseases-related-to-travel/hepatitis-b.htm]
Screening for hepatitis C
Patients with any of the following risk factors for hepatitis C should be tested using quantitative RNA-PCR:
The management guidelines, in Section 6 are provided according to the results of the baseline assessment of hepatitis C viral load.
Primary purpose
Allocation
Interventional model
Masking
74 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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