Status:

COMPLETED

A Study of Letrozole in the Treatment of Endometrial Cancer

Lead Sponsor:

Novartis Pharmaceuticals

Collaborating Sponsors:

Canadian Cancer Trials Group

Conditions:

Recurrent and Metastatic Endometrial Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2000

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    36 Patients enrolled

    Trial Details

    Trial ID

    NCT00333086

    Start Date

    January 1 2000

    Last Update

    April 19 2012

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    Novartis Investigative Site

    Heidelberg, Germany