Brief Title
Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer
Official Title
Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria
Condition
Endometrial Cancer
Intervention
everolimus
Study Arms / Comparison Groups
Single arm
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
44
Start Date
March 2008
Primary Completion Date
May 2011
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Laure Chauvenet, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00870337
Organization ID
CDR0000633321
Secondary IDs
ARCAGY-ENDORAD
Responsible Party
Sponsor
Study Sponsor
ARCAGY/ GINECO GROUP
Study Sponsor
Laure Chauvenet, MD, Principal Investigator, Hotel Dieu de Paris
Verification Date
October 2014