Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: letrozole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 |
- Objective tumour response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- duration of response and time to progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- tumour response [ Time Frame: 3 years ] [ Designated as safety issue: No ]Correlation of tumour response with pre-treatment ER/PR status, histological grade and aromatase levels.
| Enrollment: | 33 |
| Study Start Date: | January 2000 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Letrozole
Letrozole 2.5 mg po daily
|
Drug: letrozole
2.5 mg of letrozole per day
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00004251 History of Changes |
| Other Study ID Numbers: | I126, CAN-NCIC-IND126, NOVARTIS-FEM-CA-02, CDR0000067498 |
| Study First Received: | January 28, 2000 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by NCIC Clinical Trials Group:
|
stage IV endometrial carcinoma recurrent endometrial carcinoma endometrial adenocarcinoma endometrial adenosquamous cell carcinoma |
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 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013