Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

Endometrial Cancer Clinical Trial

— ENDORAD  

Official title:

Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870337
• Other study ID #: CDR0000633321
• Secondary ID: ARCAGY-ENDORADNO
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2009
• Last updated: October 28, 2014
• Start date: March 2008

Study information

• Verified date: October 2014
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• everolimus

Locations

Country	Name	City	State
France	Hotel Dieu de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria		3 months	No