Status and phase
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Treatments
Study type
Funder types
Identifiers
About
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.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral everolimus daily in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed monthly for 3 months and then every 3 months thereafter.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the endometrium
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:
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:
Primary purpose
Allocation
Interventional model
Masking
44 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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