Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00870337
First received: March 26, 2009
Last updated: May 12, 2011
Last verified: July 2009

March 26, 2009
May 12, 2011
March 2008
May 2011   (final data collection date for primary outcome measure)
Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00870337 on ClinicalTrials.gov Archive Site
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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

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.

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 and complete response rate after 3 months of treatment with everolimus in these patients.
  • Evaluate the duration of response in these patients.
  • Evaluate the clinical benefit after 6 months of treatment with everolimus in these patients.
  • Evaluate the time to progression in these patients.
  • Evaluate the progression-free and overall survival of these patients.
  • Evaluate the nature, frequency, and severity of side effects of everolimus in these patients.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Endometrial Cancer
Drug: everolimus
Not Provided
Ray-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
Not Provided
May 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00870337
CDR0000633321, ARCAGY-ENDORAD, NOVARTIS-ARCAGY-ENDORAD, ARCAGY-GINECO-EN101, INCA-RECF0512, EUDRACT-2007-003002-10
Not Provided
Not Provided
Hotel Dieu Hospital
Not Provided
Principal Investigator: Laure Chauvenet, MD Hotel Dieu de Paris
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP