Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005649
Status:
COMPLETED
Last Update Posted:
2017-08-16
First Post:
2000-05-02
Brief Title:
Paclitaxel and Capecitabine in Treating Women With Metastatic Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Combination Study of Capecitabine and Standard Paclitaxel Therapy as First or Second Line Therapy in Women With Metastatic Breast Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-08
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 paclitaxel and capecitabine in treating women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of paclitaxel and capecitabine in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the safety response rate and efficacy of combination therapy with paclitaxel and capecitabine as first or second line therapy in women with metastatic breast cancer
OUTLINE This is a multicenter study Patients receive paclitaxel IV over 3 hours on day 1 and capecitabine orally twice daily on days 1-14 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed for survival status every 3 months upon completion of treatment
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive paclitaxel IV over 3 hours on day 1 and capecitabine orally twice daily on days 1-14 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed for survival status every 3 months upon completion of treatment
PROJECTED ACCRUAL A total of 60 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 |
|---|---|---|---|
| ROCHE-M66104C | None | None | None |