Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027716
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
2001-12-07
Brief Title:
Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Multi-Institutional Open-Label Two-Group Phase II Study of PS-341 LDP-341 NSC 681239 in Patients With Advanced or Metastatic Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have advanced or metastatic sarcoma
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have advanced or metastatic sarcoma
Detailed Description:
OBJECTIVES
Determine the response rate in patients with advanced or metastatic sarcoma treated with bortezomib
Correlate levels of cyclins D1 E p21 WAF1 p27 Kip1 mdm2 p53 and Ki67 with response in patients treated with this drug
OUTLINE This is an open-label multicenter study Patients are stratified according to disease stratum I soft tissue sarcoma not specified in stratum II osteogenic sarcoma arising from soft tissues or gastrointestinal stromal tumor vs stratum II Ewings sarcoma of soft tissue or bone rhabdomyosarcoma or osteogenic sarcoma of bone Stratum I closed to accrual as of 101703
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for stratum I within 5-11 months and 21-41 patients will be accrued for stratum II within 105-22 months Stratum I closed to accrual as of 101703
Determine the response rate in patients with advanced or metastatic sarcoma treated with bortezomib
Correlate levels of cyclins D1 E p21 WAF1 p27 Kip1 mdm2 p53 and Ki67 with response in patients treated with this drug
OUTLINE This is an open-label multicenter study Patients are stratified according to disease stratum I soft tissue sarcoma not specified in stratum II osteogenic sarcoma arising from soft tissues or gastrointestinal stromal tumor vs stratum II Ewings sarcoma of soft tissue or bone rhabdomyosarcoma or osteogenic sarcoma of bone Stratum I closed to accrual as of 101703
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for stratum I within 5-11 months and 21-41 patients will be accrued for stratum II within 105-22 months Stratum I closed to accrual as of 101703
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-1757 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069060 | REGISTRY | None | None |