Know Cancer

or
forgot password

Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Laure Chauvenet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hotel Dieu de Paris

Authority:

United States: Federal Government

Study ID:

CDR0000633321

NCT ID:

NCT00870337

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • stage IV endometrial carcinoma
  • endometrial adenocarcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location