Clinical trial · Interventional
Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer
Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer
NCT00870337CI-TRIAL-00015932ENDORADcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- interventionNames
- Drug: everolimus
Primary outcomes (1)
- measure
- Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDRay-Coquard I, Favier L, Weber B, Roemer-Becuwe C, Bougnoux P, Fabbro M, Floquet A, Joly F, Plantade A, Paraiso D, Pujade-Lauraine E. Everolimus as second- or third-line treatment of advanced endometrial cancer: ENDORAD, a phase II trial of GINECO. Br J Cancer. 2013 May 14;108(9):1771-7. doi: 10.1038/bjc.2013.183. Epub 2013 Apr 23. PMID 23612453
- DERIVEDTredan O, Treilleux I, Wang Q, Gane N, Pissaloux D, Bonnin N, Petit T, Cretin J, Bonichon-Lamichhane N, Priou F, Lavau-Denes S, Mari V, Freyer G, Lebrun D, Alexandre J, Ray-Coquard I. Predicting everolimus treatment efficacy in patients with advanced endometrial carcinoma: a GINECO group study. Target Oncol. 2013 Dec;8(4):243-51. doi: 10.1007/s11523-012-0242-9. Epub 2012 Dec 13. PMID 23238879