Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00870337
First received: March 26, 2009
Last updated: May 12, 2011
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Drug: everolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: March 2008
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870337

Locations
France
Hotel Dieu de Paris
Paris, France, 75181
Sponsors and Collaborators
Hotel Dieu Hospital
Investigators
Principal Investigator: Laure Chauvenet, MD Hotel Dieu de Paris
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00870337     History of Changes
Other Study ID Numbers: CDR0000633321, ARCAGY-ENDORAD, NOVARTIS-ARCAGY-ENDORAD, ARCAGY-GINECO-EN101, INCA-RECF0512, EUDRACT-2007-003002-10
Study First Received: March 26, 2009
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma
stage IV endometrial carcinoma
endometrial adenocarcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 01, 2014