Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107276
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2005-04-05
Brief Title:
S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Trial of Simple Oral Therapy Continuous Oral Cyclophosphamide and Capecitabine in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-07
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 such as cyclophosphamide and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one chemotherapy drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving cyclophosphamide together with capecitabine works in treating women with stage IV breast cancer
PURPOSE This phase II trial is studying how well giving cyclophosphamide together with capecitabine works in treating women with stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the response rate complete and partial confirmed and unconfirmed in women with stage IV breast cancer treated with oral cyclophosphamide and oral capecitabine
Determine the progression-free survival and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral cyclophosphamide once daily on days 1-14 and oral capecitabine twice daily on days 8-21 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then at weeks 7 13 19 and 25
After completion of study treatment patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 96 patients will be accrued for this study within 4 years
Determine the response rate complete and partial confirmed and unconfirmed in women with stage IV breast cancer treated with oral cyclophosphamide and oral capecitabine
Determine the progression-free survival and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral cyclophosphamide once daily on days 1-14 and oral capecitabine twice daily on days 8-21 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then at weeks 7 13 19 and 25
After completion of study treatment patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 96 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0430 | OTHER | None | None |