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Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer (ENDORAD)

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
everolimus
Sponsored by
ARCAGY/ GINECO GROUP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring recurrent endometrial carcinoma, stage IV endometrial carcinoma, endometrial adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hotel Dieu de Paris

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Outcomes

Primary Outcome Measures

Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria

Secondary Outcome Measures

Full Information

First Posted
March 26, 2009
Last Updated
October 28, 2014
Sponsor
ARCAGY/ GINECO GROUP
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1. Study Identification

Unique Protocol Identification Number
NCT00870337
Brief Title
Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer
Acronym
ENDORAD
Official Title
Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCAGY/ GINECO GROUP

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 well everolimus works in treating patients with relapsed or metastatic endometrial cancer.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
recurrent endometrial carcinoma, stage IV endometrial carcinoma, endometrial adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
everolimus
Primary Outcome Measure Information:
Title
Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laure Chauvenet, MD
Organizational Affiliation
Hotel Dieu de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu de Paris
City
Paris
ZIP/Postal Code
75181
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23612453
Citation
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.
Results Reference
derived
PubMed Identifier
23238879
Citation
Tredan 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.
Results Reference
derived

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Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

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