Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025506
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2001-10-11
Brief Title:
Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma 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 Carcinosarcoma 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:
This phase II trial is studying how well thalidomide works in treating patients with carcinosarcoma of the uterus that has come back or that does not go to remission decrease or disappear but may still be in the body despite treatment Thalidomide may stop the growth of cancer by stopping blood flow to the tumor
Detailed Description:
OBJECTIVES Primary 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 carcinosarcoma
II Determine the nature and degree of toxicity of this drug in these patients
Secondary I Determine the partial and complete response rates in patients treated with this drug
II Determine the duration of PFS and overall survival of patients treated with this drug
III Determine the effect of this drug on initial performance status and histological grade in these patients
IV Correlate serum and plasma biomarkers including vascular endothelial growth factor and basic fibroblast growth factor with clinical outcome ie 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 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
PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study within 3 years
II Determine the nature and degree of toxicity of this drug in these patients
Secondary I Determine the partial and complete response rates in patients treated with this drug
II Determine the duration of PFS and overall survival of patients treated with this drug
III Determine the effect of this drug on initial performance status and histological grade in these patients
IV Correlate serum and plasma biomarkers including vascular endothelial growth factor and basic fibroblast growth factor with clinical outcome ie 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 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
PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study within 3 years
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-2012-02421 | REGISTRY | None | None |
| CDR0000068967 | None | None | None |
| GOG-0230B | OTHER | None | None |
| GOG-0230B | OTHER | None | None |