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A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer

Phase 2
18 Years
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer

OBJECTIVES: I. Determine the efficacy of letrozole, in terms of objective tumor response and
time to progression, in women with recurrent or metastatic endometrial cancer. II. Determine
the toxicity of letrozole in these patients. III. Determine the relationship between tumor
receptor status, histologic grade, tumor aromatase activity, and tumor response in these

OUTLINE: Patients receive an oral letrozole tablet daily. Treatment continues for patients
with complete or partial response until disease progression or unacceptable toxicity.
Patients with stable disease may discontinue therapy after 24 weeks. Patients are followed
at 1 month and then every 3 months until death.

PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study within 12-18 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven, recurrent or metastatic, adenocarcinoma or
adenosquamous carcinoma of the endometrium not curable by surgery and/or radiotherapy
Failed one prior progestin therapy for advanced/metastatic disease OR Considered for
letrozole as first line therapy of advanced/metastatic disease No clear cell or papillary
serous histology, uterine sarcomas, mixed muellerian tumors, and/or adenosarcomas At least
one site of measurable disease by clinical exam, CT, or MRI scan Bone lesion(s) are not
considered measurable No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Menopausal status:
Postmenopausal (surgical or natural) Life expectancy: At least 12 weeks Hematopoietic:
Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin less than upper limit of normal (ULN) AST or ALT no greater than 2 times ULN
Alkaline phosphatase less than 2 times ULN Renal: Creatinine no greater than 2 times ULN
Other: No other malignancy within the past 5 years, except: Adequately treated basal or
squamous cell skin cancer Carcinoma in situ of the cervix No other concurrent medical
illness that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for advanced/metastatic disease At least 4 weeks since prior adjuvant
chemotherapy Endocrine therapy: See Disease Characteristics No more than one prior
progestational hormone therapy regimen for advanced/metastatic disease At least 1 week
since prior hormonal therapy No prior tamoxifen or other aromatase inhibitor therapy
Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy
Concurrent radiotherapy for symptomatic metastatic lesions allowed Surgery: See Disease
Characteristics Other: No other concurrent anticancer therapy No other concurrent
investigational therapy

Type of Study:


Study Design:

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

Outcome Measure:

Objective tumour response

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Anthony Fyles, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

January 2011

Related Keywords:

  • Endometrial Cancer
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma