Brief Title
Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer
Official Title
A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of letrozole in treating women who have
recurrent or metastatic endometrial cancer.
Detailed Description
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
patients.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective tumour response
Secondary Outcome
duration of response and time to progression
Condition
Endometrial Cancer
Intervention
letrozole
Study Arms / Comparison Groups
Letrozole
Description: Letrozole 2.5 mg po daily
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
33
Start Date
January 19, 2000
Completion Date
January 18, 2011
Primary Completion Date
September 13, 2002
Eligibility 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
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Anthony Fyles, MD, ,
Administrative Informations
NCT ID
NCT00004251
Organization ID
I126
Secondary IDs
CAN-NCIC-IND126
Responsible Party
Sponsor
Study Sponsor
NCIC Clinical Trials Group
Study Sponsor
Anthony Fyles, MD, Study Chair, Princess Margaret Hospital, Canada
Verification Date
April 2020