Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

NCT00870337 | Completed Phase 2 DMC

• 6 other identifiers: CDR0000633321ARCAGY-ENDORADNOVARTIS-ARCAGY-ENDORADARCAGY-GINECO-EN101INCA-RECF0512EUDRACT-2007-003002-10
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinoma; stage IV endometrial carcinoma; endometrial adenocarcinoma

Outcome Measures

Primary Outcomes (1)

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

  3 months

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: everolimus

Interventions

everolimus DRUG

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead

Study Sites (1)

Hotel Dieu de Paris

Paris, 75181, France

Location

Related Publications (2)

• 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.

  PMID: 23612453 DERIVED

• 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.

  PMID: 23238879 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Laure Chauvenet, MD

  Hotel Dieu de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: March 1, 2008
• Primary Completion: May 1, 2011
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

FR (1)