Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004251
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2000-01-28
Brief Title:
Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067498 | OTHER | PDQ | None |
| CAN-NCIC-IND126 | OTHER | None | None |
| NOVARTIS-FEM-CA-02 | OTHER | None | None |