Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer (ENDORAD)

A

ARCAGY/ GINECO GROUP

Status and phase

Completed
Phase 2

Conditions

Endometrial Cancer

Treatments

Drug: everolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT00870337
ARCAGY-ENDORAD
ARCAGY-GINECO-EN101
NOVARTIS-ARCAGY-ENDORAD
CDR0000633321
EUDRACT-2007-003002-10
INCA-RECF0512

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

44 participants in 1 patient group

Single arm
Experimental group
Treatment:
Drug: everolimus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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