Phase II Study on Letrozole in Patients With Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer
Inclusion Criteria:
- Signed informed consent
- Age > 18 years
- Presence of histologically proven adenocarcinoma or adenosquamous carcinoma of the
endometrium
- Presence of advanced or recurrent endometrial cancer, FIGO stage I-IV, incurable with
surgery and/or radiation therapy
- Documented ER and/or PgR positive endometrial cancer. Hormone receptor positivity is
defined according to routine practice at each participating laboratory.
- Patient must be postmenopausal defined as
- Age ≥55 years.
- Age <55 but no spontaneous menses for at least 1 year.
- Age <55 and spontaneous menses within the past 1 year, but currently amenorrheic
(e.g., spontaneous or secondary to hysterectomy), and with postmenopausal
gonadotrophin levels (luteinizing hormone and follicle stimulating hormone
levels >40 IU/L) or postmenopausal estradiol levels (<5 ng/dL) or according to
the definition of "postmenopausal range" for the laboratory involved.
- Bilateral oophorectomy
- Radiation menopause
- Presence of measurable disease (by clinical/radiological examination - according to
RECIST criteria : minimum indicator lesion size : 20 mm (unless spiral CT scan in
which case > 10 mm)
- ECOG performance status of 0, 1 or 2
- Adequate bone marrow function (WBC ≥ 3.5 x 1'000'000'000/L and platelets ≥ 100.0 x
1'000'000'000/L) and hemoglobin > 10.0 g/dl
- Adequate renal function (creatinine < 120 µmol/L) and hepatic function (bilirubin <
25 µmol/L, AST (SGOT < 60 U/L)
- Minimum life expectancy of at least 6 months
- Patients who are accessible for treatment and follow-up
Exclusion Criteria:
- Presence of non-measurable disease only
- Other concomitant anti-cancer treatment (except external radiation treatment [XRT]
for symptomatic metastatic lesions if other assessable untreated lesions are present)
- Prior treatment with aromatase inhibitors or anti-estrogens (up to one previous
progestational hormone therapy regimen for recurrent disease is permitted)
- Clear cell or papillary serous histology, uterine sarcomas, mixed Mullerian tumors
(MMT) and/or adenosarcomas
- Other concurrent malignant disease with the exception of cone-biopsied in situ
carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma
of the skin, or other curable cancers e.g. Hodgkin`s disease or non-Hodgkin lymphoma
(NHL), provided 5 years have elapsed from completion of therapy, and there has been
no recurrence
- Known central nervous system (CNS) metastases, bilateral diffuse lymphangiosis
carcinoma of the lung (>50 % of lung involvement, or dyspnea at rest requiring
supplemental oxygen therapy), evidence of metastases estimated as more than a third
of the liver as defined by sonogram and/or CT scan
- Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or
hyperthyroidism, Cushing`s Syndrome, Addison`s disease (treated or untreated)
- Unstable angina and uncontrolled cardiac disease
- Treatment with other investigational drugs (drugs not marketed for any indication)
within the past 30 days and/or the concomitant use of investigational drugs
- A history of non-compliance to medical regimens and patients who, in the opinion of
the investigator, are unlikely to cooperate fully during the study
- Inability to swallow pills
Additional protocol-defined inclusion/exclusion criteria may apply.