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

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)

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44 participants in 1 patient group

Single arm

Experimental group

Treatment:

Drug: everolimus