Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052390
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2003-01-24
Brief Title:
Doxorubicin and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Soft Tissue Sarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multi-Institutional Open-Label Phase II Study Of Doxorubicin And Bevacizumab Anti-VEFG Monoclonal Antibody NSC 704865 For Patients With Advanced Or Metastatic Soft-Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2004-02
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor Combining doxorubicin with bevacizumab may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining doxorubicin with bevacizumab in treating patients who have locally recurrent or metastatic soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of combining doxorubicin with bevacizumab in treating patients who have locally recurrent or metastatic soft tissue sarcoma
Detailed Description:
OBJECTIVES
Determine the response rate partial and complete in patients with locally recurrent or metastatic soft tissue sarcoma treated with doxorubicin and bevacizumab
Determine the tolerability of this regimen in these patients
Determine the toxicity profile of this regimen in these patients
Determine whether pre-treatment plasma vascular endothelial growth factor level or microvessel density of tumor samples from these patients predicts response to this regimen
OUTLINE This is a multicenter study
Patients receive doxorubicin IV over 5-10 minutes followed by bevacizumab IV over 30-90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients with responding disease after reaching the maximum dose of doxorubicin may continue bevacizumab alone
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 17-37 patients will be accrued for this study within 133 months
Determine the response rate partial and complete in patients with locally recurrent or metastatic soft tissue sarcoma treated with doxorubicin and bevacizumab
Determine the tolerability of this regimen in these patients
Determine the toxicity profile of this regimen in these patients
Determine whether pre-treatment plasma vascular endothelial growth factor level or microvessel density of tumor samples from these patients predicts response to this regimen
OUTLINE This is a multicenter study
Patients receive doxorubicin IV over 5-10 minutes followed by bevacizumab IV over 30-90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients with responding disease after reaching the maximum dose of doxorubicin may continue bevacizumab alone
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 17-37 patients will be accrued for this study within 133 months
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-2270 | None | None | None |
| MSKCC-02041 | None | None | None |