Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002937
Status:
COMPLETED
Last Update Posted:
2010-01-06
First Post:
1999-11-01
Brief Title:
Paclitaxel With or Without PSC 833 in Treating Patients With Metastatic Breast Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase II Randomized Study of Paclitaxel Versus Paclitaxel PSC833 for Advanced Breast Cancer Recurring Less Than 6 Months Since Adjuvant or as Second Line for Advanced Disease
Status:
COMPLETED
Status Verified Date:
2010-01
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 Randomized phase II trial to compare the effectiveness of paclitaxel with or without PSC 833 in treating patients with metastatic breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of paclitaxel with or without PSC 833 in treating patients with metastatic breast cancer
Detailed Description:
OBJECTIVES I Evaluate the response rate and time to treatment failure of paclitaxel with and without the P-glycoprotein Pgp antagonist PSC 833 in advanced breast cancer II For each treatment arm relate paclitaxel AUC area under curve andor time above 05 umL to myelosuppression andor response III To obtain preliminary estimates of MDR in this group of patients by measuring MDR1-Pgp immunostaining in pretreatment biopsies in 20 patients and biopsies taken at the time of progression
OUTLINE This is a randomized study Patients are stratified according to three criteria 1 treatment within 2 years of adjuvant chemotherapy vs progression on chemotherapy for advanced disease 2 measurable vs evaluable disease 3 institution Patients receive paclitaxel alone or paclitaxel plus PSC 833 In the first arm paclitaxel alone is administered by continuous infusion over 3 hours once every 3 weeks In the second arm PSC 833 is administered PO four times a day for 3 days paclitaxel is administered by continuous infusion over 3 hours on day 2 Courses repeat every 3 weeks
PROJECTED ACCRUAL Approximately 70 patients will be accrued per year in this study
OUTLINE This is a randomized study Patients are stratified according to three criteria 1 treatment within 2 years of adjuvant chemotherapy vs progression on chemotherapy for advanced disease 2 measurable vs evaluable disease 3 institution Patients receive paclitaxel alone or paclitaxel plus PSC 833 In the first arm paclitaxel alone is administered by continuous infusion over 3 hours once every 3 weeks In the second arm PSC 833 is administered PO four times a day for 3 days paclitaxel is administered by continuous infusion over 3 hours on day 2 Courses repeat every 3 weeks
PROJECTED ACCRUAL Approximately 70 patients will be accrued per year in 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 |
|---|---|---|---|
| NCI-H97-1137 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA063265 |
| U01CA063265 | NIH | None | None |
| CHNMC-96002 | None | None | None |