Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

NCT ID: NCT00870337

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31

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.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Group Type: EXPERIMENTAL

everolimus

Intervention Type: DRUG

Interventions

everolimus

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ARCAGY/ GINECO GROUP

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laure Chauvenet, MD

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu de Paris

Locations

Hotel Dieu de Paris

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 23612453 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23238879 (View on PubMed)

Other Identifiers

ARCAGY-ENDORAD

Identifier Type: -

Identifier Source: secondary_id

NOVARTIS-ARCAGY-ENDORAD

Identifier Type: -

Identifier Source: secondary_id

ARCAGY-GINECO-EN101

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0512

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2007-003002-10

Identifier Type: -

Identifier Source: secondary_id

CDR0000633321

Identifier Type: -

Identifier Source: org_study_id