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A PHASE II STUDY OF LETROZOLE IN PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER


Phase 2
18 Years
N/A
Not Enrolling
Female
Recurrent and Metastatic Endometrial Cancer

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Trial Information

A PHASE II STUDY OF LETROZOLE IN PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CFEM345ADE03

NCT ID:

NCT00333086

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Recurrent and Metastatic Endometrial Cancer
  • Endometrial Cancer
  • Aromatase inhibitor
  • Letrozole
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

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