Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025467
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2001-10-11
Brief Title:
Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of Thalidomide NSC 66847 IND 48832 in the Treatment of Recurrent of Persistent Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent endometrial cancer Thalidomide may stop the growth of cancer by stopping blood flow to the tumor
Detailed Description:
OBJECTIVES
I Determine the antitumor cytostatic activity of thalidomide in terms of 6-month progression-free survival in patients with recurrent or persistent endometrial carcinoma
II Determine the nature and degree of toxicity of this drug in these patients III Determine the partial and complete response rates in patients treated with this drug
IV Determine the duration of progression-free and overall survival in patients treated with this drug
V Determine the effect of this drug on initial performance status and histological grade in these patients
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I Determine the antitumor cytostatic activity of thalidomide in terms of 6-month progression-free survival in patients with recurrent or persistent endometrial carcinoma
II Determine the nature and degree of toxicity of this drug in these patients III Determine the partial and complete response rates in patients treated with this drug
IV Determine the duration of progression-free and overall survival in patients treated with this drug
V Determine the effect of this drug on initial performance status and histological grade in these patients
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| CDR0000068964 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA027469 |
| GOG-0229-B | None | None | None |
| U10CA027469 | NIH | None | None |