Phase II study on letrozole in patients with advanced or recurrent hormone receptor positive endometrial cancer. - deFEND
- Conditions
- endometrial cancer
- Registration Number
- EUCTR2004-003886-34-DE
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
To be eligible for the study a patient must fulfill all of the following 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 109/L and platelets >= 100.0 x 109/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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
To be eligible for the study a patient must not fulfill any of the following criteria:
•presence of non-measurable disease only
•other concomitant anti-cancer treatment (except 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 NHL, provided 5 years have elapsed from completion of therapy, and there has been no recurrence
•known CNS metastases, bilateral diffuse lymphangiosis carcinomatosa 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: clinical response rate (CR/PR);Secondary Objective: -time to progression (TTP)<br>-overall survival (OS)<br>-safety<br>;Primary end point(s): assessment of clinical response rate
- Secondary Outcome Measures
Name Time Method