Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189137
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2005-09-13
Brief Title:
Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase II Evaluation of Ifosfamide Plus Doxorubicin Filgrastim Versus Gemcitabine Plus Docetaxel Filgrastim in the Treatment of Localized Poor Prognosis Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2015-11
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:
The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugsgemcitabine and docetaxelas compared to a standard combination of chemotherapy drugs ifosfamide and doxorubicin
Detailed Description:
The purpose of this study is to explore the relative activity and toxicity of a newer combination of chemotherapy drugs gemcitabine and docetaxel as compared to a standard combination of chemotherapy drugs ifosfamide and doxorubicin
Ifosfamide and Doxorubicin given in combination are recognized as a standard of care for some types of sarcoma Both gemcitabine and docetaxel are approved by the US Food and Drug Administration FDA for the treatment of some cancers cancers of the pancreas lung because patients with those cancers treated with either gemcitabine or docetaxel experienced shrinkage of their tumor or improvement in their symptoms However neither gemcitabine or docetaxel is approved for sarcoma but the combination of gemcitabine and docetaxel is a standard treatment for advanced sarcoma
Ifosfamide and Doxorubicin given in combination are recognized as a standard of care for some types of sarcoma Both gemcitabine and docetaxel are approved by the US Food and Drug Administration FDA for the treatment of some cancers cancers of the pancreas lung because patients with those cancers treated with either gemcitabine or docetaxel experienced shrinkage of their tumor or improvement in their symptoms However neither gemcitabine or docetaxel is approved for sarcoma but the combination of gemcitabine and docetaxel is a standard treatment for advanced sarcoma
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 |
|---|---|---|---|
| HUM 44800 | OTHER | University of Michigan IRBMED | None |