Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003946
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
1999-11-01
Brief Title:
Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2004-07
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 Hormone therapy may be an effective treatment for endometrial cancer
PURPOSE Phase II trial to study the effectiveness of danazol in treating patients with advanced or recurrent endometrial cancer
PURPOSE Phase II trial to study the effectiveness of danazol in treating patients with advanced or recurrent endometrial cancer
Detailed Description:
OBJECTIVES I Assess the antitumor activity of danazol in patients with advanced or recurrent endometrial cancer II Determine the nature and toxicity of danazol in these patients
OUTLINE Patients receive oral danazol 4 times per day for at least 4 weeks Patients with partial response complete response or stable disease continue treatment in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 23-56 patients will be accrued for this study within 26 months
OUTLINE Patients receive oral danazol 4 times per day for at least 4 weeks Patients with partial response complete response or stable disease continue treatment in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 23-56 patients will be accrued for this study within 26 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| GOG-0180 | None | None | None |