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

October 28, 2014 updated by: ARCAGY/ GINECO GROUP

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75181
        • Hotel Dieu de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
Drug: everolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Laure Chauvenet, MD, Hotel Dieu de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000633321
  • ARCAGY-ENDORAD
  • NOVARTIS-ARCAGY-ENDORAD
  • ARCAGY-GINECO-EN101
  • INCA-RECF0512
  • EUDRACT-2007-003002-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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