Status:
COMPLETED
Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer
Lead Sponsor:
ARCAGY/ GINECO GROUP
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 w...
Detailed Description
OBJECTIVES: Primary * Estimate the rate of non-progression after 3 months of treatment with everolimus in patients with relapsed or metastatic endometrial cancer. Secondary * Evaluate the partial ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00870337
Start Date
March 1 2008
Last Update
October 29 2014
Active Locations (1)
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1
Hotel Dieu de Paris
Paris, France, 75181