Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003683
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Treatment of Sarcomatous Kidney Cancer That is Metastatic in Adults With Doxorubicin and Ifosfamide Phase II Study
Status:
COMPLETED
Status Verified Date:
2021-02
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 Combining more than one chemotherapy drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining doxorubicin and ifosfamide in treating patients who have metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of combining doxorubicin and ifosfamide in treating patients who have metastatic kidney cancer
Detailed Description:
OBJECTIVES I Determine the efficacy in terms of objective response after treatment with ifosfamide and doxorubicin in patients with metastatic sarcomatoid renal cell cancer II Determine the toxicity of this regimen in these patients III Determine the effect of this regimen on the survival of these patients
OUTLINE This is a multicenter study Patients receive doxorubicin IV on day 1 and ifosfamide IV over 2 hours on days 1 and 2 Treatment is repeated every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 3 years
OUTLINE This is a multicenter study Patients receive doxorubicin IV on day 1 and ifosfamide IV over 2 hours on days 1 and 2 Treatment is repeated every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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-REINSARDI | None | None | None |
| EU-98057 | None | None | None |