Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217607
Status:
COMPLETED
Last Update Posted:
2016-08-30
First Post:
2005-09-20
Brief Title:
Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Multicentric Phase II Study Evaluating the Efficacy and Toxicity of Weekly Paclitaxel in Locally Advanced or Metastatic Soft Tissue Angiosarcomas That Cannot be Treated by Surgery
Status:
COMPLETED
Status Verified Date:
2016-08
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 such as paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery
PURPOSE This phase II trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the 2-month objective response rate in patients with locally advanced or metastatic unresectable soft tissue angiosarcoma or lymphangiosarcoma treated with paclitaxel
Secondary
Determine the 4- and 6-month response rate in patients treated with this drug
Determine tolerability of this drug in these patients
Determine the time to disease progression and overall survival of patients treated with this drug
Determine the clinical criteria predicting response in patients treated with this drug
Correlate the efficacy of this drug with the expression of genes involved in angiogenesis regulation in these patients
OUTLINE This is a multicenter study
Patients receive paclitaxel IV on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study
Primary
Determine the 2-month objective response rate in patients with locally advanced or metastatic unresectable soft tissue angiosarcoma or lymphangiosarcoma treated with paclitaxel
Secondary
Determine the 4- and 6-month response rate in patients treated with this drug
Determine tolerability of this drug in these patients
Determine the time to disease progression and overall survival of patients treated with this drug
Determine the clinical criteria predicting response in patients treated with this drug
Correlate the efficacy of this drug with the expression of genes involved in angiogenesis regulation in these patients
OUTLINE This is a multicenter study
Patients receive paclitaxel IV on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study
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 |
|---|---|---|---|
| FRE-FNCLCC-SARCOME-060409 | None | None | None |
| EU-20517 | None | None | None |