Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110084
Status:
COMPLETED
Last Update Posted:
2011-06-02
First Post:
2005-05-03
Brief Title:
ABI-007 Nab-Paclitaxel and Gemcitabine in Treating Women With Metastatic Breast Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase II Trial of Weekly Nab Nanoparticle Albumin Bound-Paclitaxel Nab-paclitaxel Abraxane in Combination With Gemcitabine in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-05
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 ABI-007Nab-PaclitaxelNanoparticle Albumin Bound-Paclitaxel and gemcitabine 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 drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer
PURPOSE This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of ABI-007 and gemcitabine in terms of response rate in women with metastatic breast cancer
Determine the toxicity profile of this regimen in terms of incidence and severity of observed toxic effects in these patients
Secondary
Determine the time to disease progression and survival of patients treated with this regimen
OUTLINE This is a multicenter study Patients receive ABI-007 IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for up to 5 years
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study within 20 months
Primary
Determine the antitumor activity of ABI-007 and gemcitabine in terms of response rate in women with metastatic breast cancer
Determine the toxicity profile of this regimen in terms of incidence and severity of observed toxic effects in these patients
Secondary
Determine the time to disease progression and survival of patients treated with this regimen
OUTLINE This is a multicenter study Patients receive ABI-007 IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for up to 5 years
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study within 20 months
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 |
|---|---|---|---|
| U10CA025224 | NIH | None | None |
| N0531 | OTHER | None | None |
| 855-05 | OTHER | None | None |
| N0433 | OTHER | NCCTG Old Protocol | httpsreporternihgovquickSearchU10CA025224 |