Letrozole in the Treatment of Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer

NCT ID: NCT00171808

Last Updated: 2016-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30

Brief Summary

In Western industrialized countries, endometrial cancer is the most common malignancy of the female reproductive tract.

The general therapy options are surgery, radiotherapy, chemotherapy and endocrine therapy. This trial will investigate the efficacy and safety of letrozole in the treatment of advanced or recurrent hormone receptor-positive endometrial cancer .

Conditions

Endometrial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Letrozole

Group Type: EXPERIMENTAL

Letrozole

Intervention Type: DRUG

Interventions

Letrozole

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

Ebersberg, Germany

Celle, , Germany

Heidelberg, Germany

Ebersberg, , Germany

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Ebersberg, Germany

Hamburg, , Germany

Novartis Investigative Site

Hamburg, , Germany

Celle, Germany

Hanover, , Germany

Tuebingen, Germany

Heidelberg, , Germany

Novartis Investigative Site

Karlsruhe, , Germany

Muenchen, Germany

Kiel, , Germany

Muenchen, Germany

München, , Germany

Novartis Investigative Site

München, , Germany

Novartis Investigative Site

Oberaudorf, , Germany

Novartis Investigative Site

Rostock, , Germany

Novartis Investigative Site

Tübingen, , Germany

Hannover, Germany

Wolfsburg, , Germany

Countries

Germany

Related Links

http://journals.lww.com/ijgc/Documents/ESGO%202011%20Abstracts.pdf

Abstract Page 39 (ISSN 1048891X)

Other Identifiers

EudraCT-Number: 2004-003886-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

CFEM345ADE08

Identifier Type: -

Identifier Source: org_study_id