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A Study of Letrozole in the Treatment of Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
NCIC CTG
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00333086
First received: June 1, 2006
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

Currently available treatments for endometrial cancer are associated with limited efficacy and significant toxicity. This study will assess the safety and efficacy of letrozole, an aromatase inhibitor, on endometrial cancer.


Condition Intervention Phase
Recurrent and Metastatic 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: A PHASE II STUDY OF LETROZOLE IN PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Response rates (complete response, partial response, no change, progressive disease) measured by tumor marker assessments and radiologic imaging at week 12 then every 12 weeks x 1 year followed by every 16 weeks

Secondary Outcome Measures:
  • Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels

Enrollment: 36
Study Start Date: January 2000
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion criteria

  • Postmenopausal women with recurrent or metastatic adeno- or adenosquamous carcinoma of the endometrium
  • No adjuvant therapy
  • Up to one prior hormonal (progestin) therapy for advanced/metastatic disease allowed
  • No chemotherapy for recurrence (adjuvant permitted)
  • Unidimensionally measurable disease
  • Good Health status 0-2 (Eastern Cooperatitve Oncology Group)
  • No prior tamoxifen or aromatase inhibitor therapy
  • No other concurrent anti-cancer treatment
  • No metastases in the central nervous system

Exclusion criteria:

Additional protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333086

Locations
Germany
Novartis Investigative Site
Heidelberg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
NCIC CTG
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00333086     History of Changes
Other Study ID Numbers: CFEM345ADE03
Study First Received: June 1, 2006
Last Updated: April 18, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Endometrial Cancer
Aromatase inhibitor
Letrozole

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

ClinicalTrials.gov processed this record on May 23, 2013