NCT00004251

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2000

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2002

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

June 17, 2004

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2011

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

2.7 years

First QC Date

January 28, 2000

Last Update Submit

April 2, 2020

Conditions

Endometrial Cancer

Keywords

stage IV endometrial carcinomarecurrent endometrial carcinomaendometrial adenocarcinomaendometrial adenosquamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective tumour response

    3 years

Secondary Outcomes (3)

  • duration of response and time to progression

    3 years

  • toxicity

    3 years

  • tumour response

    3 years

Study Arms (1)

Letrozole

EXPERIMENTAL

Letrozole 2.5 mg po daily

Drug: letrozole

Interventions

letrozoleDRUG

2.5 mg of letrozole per day

Letrozole

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Ma BB, Oza A, Eisenhauer E, Stanimir G, Carey M, Chapman W, Latta E, Sidhu K, Powers J, Walsh W, Fyles A. The activity of letrozole in patients with advanced or recurrent endometrial cancer and correlation with biological markers--a study of the National Cancer Institute of Canada Clinical Trials Group. Int J Gynecol Cancer. 2004 Jul-Aug;14(4):650-8. doi: 10.1111/j.1048-891X.2004.14419.x.

    PMID: 15304161RESULT

  • Sidhu K, Fyles A, Eisenhauer E, et al.: Phase II study of the aromatase inhibitor letrozole in endometrial carcinoma - NCIC CTG IND 126. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-2520, 2001.

    RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Anthony Fyles, MD

    Princess Margaret Hospital, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2000

First Posted

June 17, 2004

Study Start

January 19, 2000

Primary Completion

September 13, 2002

Study Completion

January 18, 2011

Last Updated

April 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share