Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or metastatic endometrial cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCAGY/ GINECO GROUP
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the endometrium

• Metastatic disease after first- or second-line chemotherapy

• Previously treated with platinum-based therapy in the adjuvant or metastatic setting

• Must have ≥ 1 measurable metastatic lesion outside previously irradiated areas

• No locally recurrent resectable tumor

• No uncontrolled brain metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-1

• ANC ≥ 1,000/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9 g/dL

• Transaminases ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)

• Alkaline phosphatase ≤ 2.5 times ULN

• Bilirubin ≤ 1.5 times ULN

• Creatinine clearance ≥ 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other cancer within the past 3 years except for curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma

• No concurrent serious and/or uncontrolled disease that would preclude study participation, including any of the following:

• Uncontrolled diabetes

• Uncontrolled hypertension

• Severe infection

• Profound malnutrition

• Unstable angina

• NYHA class III-IV congestive heart failure

• Ventricular arrhythmia

• Coronary artery disease

• Myocardial infarction within the past 6 months

• Liver disease

• Chronic renal failure

• Progressive ulceration of the upper gastrointestinal tract

• No hypersensitivity to everolimus, sirolimus, or lactose

• No abnormalities ≥ grade 3

• No psychological, familial, social, or geographical reasons that would preclude study follow-up

• No history of poor compliance to medical treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior experimental drugs (e.g., mTOR inhibitors)

• More than 21 days since prior and no other concurrent chemotherapy, hormonal therapy, or antitumor therapy

• More than 5 days since prior strong CYP3A4 inhibitors or inducers (e.g., rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, or telithromycin)

• More than 30 days since other prior treatments

• No concurrent participation in another clinical trial that would interfere with the objectives of this study

• No concurrent anticoagulation, except for 1 mg of coumadin per day or low molecular weight heparin