Letrozole as a Treatment of Endometrial Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00997373
First received: October 15, 2009
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

Some cases of endometrial cancer are dependent on estrogen for their growth. Letrozole blocks estrogen production in the body. The purpose of this study is to determine if the investigators can predict which patients might benefit from Letrozole treatment by studying the many different forms of the estrogen receptor molecule that exist within the cancer tissues. To participate in this study, the patients must be 40 years of age or older and have biopsy-proven endometrial carcinoma, either well differentiated or moderately differentiated forms. Also, to be eligible to participate in this study, the patients need to be healthy enough to have a hysterectomy. If the patients are less than age 60, they will need a blood test (FSH) to confirm that they have gone into menopause.


Condition Intervention Phase
Endometrial Carcinoma
Drug: Letrozole
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Predicting Aromatase Inhibitor Responsiveness in Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Changes in Ki67 expression after about 3 weeks of Letrozole treatment for patients with endometrial cancer [ Time Frame: At time of consent until hysterectomy (generally about 3 weeks) ] [ Designated as safety issue: No ]
  • Ki 67 regression [ Time Frame: about 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Letrozole
    2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks
    Other Names:
    • Femara
    • 4-[(4-cyanophenyl)-(1,2,4-triazol-1-yl)methyl]benzonitrile,
    • CAS number 112809-51-5
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FIGO grade 1 or 2 endometrioid adenocarcinoma of the endometrium
  • Post menopausal status must be demonstrated
  • Signed informed consent

Exclusion Criteria:

  • FIGO grade 3 endometrioid adenocarcinoma or non-endometrioid cancers of the endometrium
  • Younger than 40 or postmenopausal status not established
  • Pregnant or breastfeeding
  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: NCT00997373

Contacts
Contact: Lloyd H. Smith, MD, PhD 916-734-6945 lhsmith@ucdavis.edu

Locations
United States, California
University of California Davis Recruiting
Sacramento, California, United States, 95817
Contact: Lloyd H. Smith, MD, PhD         
Principal Investigator: Lloyd H. Smith, MD, PhD         
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Lloyd H. Smith, MD, PhD    916-734-6930      
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Lloyd H. Smith, MD, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Lloyd H. Smith, MD, PhD, University of California, Davis
ClinicalTrials.gov Identifier: NCT00997373     History of Changes
Other Study ID Numbers: 200917341, CFEM 345AUS63
Study First Received: October 15, 2009
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Endometrial Cancer
Endometrial Carcinoma
Aromatase Inhibitor
Letrozole
Femara

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Letrozole
Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014