Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014313
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2001-04-10
Brief Title:
Chemotherapy in Treating Patients With Metastatic Ewings Sarcoma or Primitive Neuroectodermal Tumor
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Phase II Study to Evaluate the Role of Weekly Cisplatin With Oral Etoposide in Ewings Sarcoma and Primitive Neuroectodermal Tumor PNET With Bone andor Bone Marrow Metatstatic Disease
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic Ewings sarcoma or primitive neuroectodermal tumor
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic Ewings sarcoma or primitive neuroectodermal tumor
Detailed Description:
OBJECTIVES
Determine the activity of cisplatin and etoposide in terms of response of patients with metastatic Ewings sarcoma or primitive neuroectodermal tumor
Assess the bone marrow and kidney toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive cisplatin IV over 3 hours on days 1 8 15 29 36 and 43 and oral etoposide daily on days 1-15 and 29-43 in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 21-45 patients will be accrued for this study within 2 years
Determine the activity of cisplatin and etoposide in terms of response of patients with metastatic Ewings sarcoma or primitive neuroectodermal tumor
Assess the bone marrow and kidney toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive cisplatin IV over 3 hours on days 1 8 15 29 36 and 43 and oral etoposide daily on days 1-15 and 29-43 in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 21-45 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| EORTC-62993 | None | None | None |