Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194766
Status:
COMPLETED
Last Update Posted:
2007-11-14
First Post:
2005-09-14
Brief Title:
Continuous Temozolomide in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Continuous Temozolomide SCH 52365 in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer Phase II
Status:
COMPLETED
Status Verified Date:
2007-11
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 determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma
Detailed Description:
Because repeated dosing of temozolomide correlates with an improved response which may be due to progressive depletion of the enzyme AT our hope is that a daily oral schedule will be the most active schedule of this agent In phase I studies doses below 85 mgm2day continuously have been well-tolerated We plan to begin dosing at 75 mgm2day for 6 weeks out of an 8 week cycle and to escalate to 85 and 100 mgm2day in patients who have no grade 34 toxicity
The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma To do this we will assess the response rate time to progression and survival in patients with advanced breast cancer or soft tissue sarcoma who are treated with temozolomide
The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma To do this we will assess the response rate time to progression and survival in patients with advanced breast cancer or soft tissue sarcoma who are treated with temozolomide
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