Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025220
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2001-10-11
Brief Title:
Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of Thalidomide NSC 66847 in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Status:
COMPLETED
Status Verified Date:
2019-07
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:
Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent cancer of the uterus Thalidomide may stop the growth of cancer by stopping blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine the antitumor cytostatic activity of thalidomide as measured by the probability of progression-free survival PFS for at least 6 months in patients with recurrent or persistent uterine leiomyosarcoma
II Determine the nature and degree of the 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 PFS and overall survival of patients treated with this drug
V Determine the effect of this drug on initial performance status in these patients
VI Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors vascular endothelial growth factor and basic fibroblast growth factor in plasma and urine of these patients
VII Assess the association of endogenous angiogenesis factors with clinical outcome PFS in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily on days 1-28 Courses repeat every 4 weeks 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 as measured by the probability of progression-free survival PFS for at least 6 months in patients with recurrent or persistent uterine leiomyosarcoma
II Determine the nature and degree of the 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 PFS and overall survival of patients treated with this drug
V Determine the effect of this drug on initial performance status in these patients
VI Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors vascular endothelial growth factor and basic fibroblast growth factor in plasma and urine of these patients
VII Assess the association of endogenous angiogenesis factors with clinical outcome PFS in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily on days 1-28 Courses repeat every 4 weeks 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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02415 | REGISTRY | None | None |
| CDR0000068939 | None | None | None |
| GOG-0231-B | OTHER | None | None |
| GOG-0231B | OTHER | None | None |