Trial record 2 of 40 for:    defend

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171808
First received: September 13, 2005
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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 .


Condition Intervention Phase
Endometrial Cancer
Drug: Letrozole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study on Letrozole in Patients With Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • clinical response rate (partial response PR and complete response CR) according to RECIST at least once during the treatment period [ Time Frame: until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression (TTP) [ Time Frame: until disease progression ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: until disease progression ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: April 2005
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole Drug: Letrozole

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Additional protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171808

Locations
Germany
Ebersberg, Germany
Celle, Germany
Heidelberg, Germany
Ebersberg, Germany
Novartis Investigative Site
Freiburg, Germany
Ebersberg, Germany
Hamburg, Germany
Novartis Investigative Site
Hamburg, Germany
Celle, Germany
Hannover, Germany
Tuebingen, Germany
Heidelberg, Germany
Novartis Investigative Site
Karlsruhe, Germany
Muenchen, Germany
Kiel, Germany
Muenchen, Germany
Muenchen, Germany
Novartis Investigative Site
Muenchen, Germany
Novartis Investigative Site
Oberaudorf, Germany
Novartis Investigative Site
Rostock, Germany
Novartis Investigative Site
Tuebingen, Germany
Hannover, Germany
Wolfsburg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00171808     History of Changes
Other Study ID Numbers: CFEM345ADE08, EudraCT-Number: 2004-003886-34
Study First Received: September 13, 2005
Last Updated: January 22, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Endometrial Cancer
Aromatase inhibitor
Advanced or recurrent
hormone receptor positive
endometrial cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Hormones
Letrozole
Aromatase Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014