Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002526
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Advanced Sarcoma
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Continuous 5 Days Infusion of High Dose Ifosfamide and Adriamycin in Patients With Advanced Sarcoma
Status:
COMPLETED
Status Verified Date:
2012-05
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of ifosfamide and doxorubicin in patients with advanced sarcoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of ifosfamide and doxorubicin in patients with advanced sarcoma
Detailed Description:
OBJECTIVES I Determine the response rate time to treatment failure and survival in patients with advanced soft tissue or gynecological sarcoma treated with high-dose ifosfamide and doxorubicin
OUTLINE Patients receive ifosfamide IV continuously on days 1-5 and doxorubicin IV on days 1-3 Filgrastim G-CSF is administered subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing through day 16 or until day 20 if blood counts have not recovered by day 16 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at treatment failure and then annually thereafter
PROJECTED ACCRUAL A total of 16-46 patients will be accrued for this study
OUTLINE Patients receive ifosfamide IV continuously on days 1-5 and doxorubicin IV on days 1-3 Filgrastim G-CSF is administered subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing through day 16 or until day 20 if blood counts have not recovered by day 16 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at treatment failure and then annually thereafter
PROJECTED ACCRUAL A total of 16-46 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 |
|---|---|---|---|
| EU-93004 | None | None | None |