Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049244
Status:
UNKNOWN
Last Update Posted:
2017-01-30
First Post:
2002-11-12
Brief Title:
BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
Sponsor:
R-Pharm
Organization:
R-Pharm
Study Overview
Official Title:
A Phase I Study of BMS-247550 in Combination With Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With a Taxane and an Anthracycline
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 I trial to study the effectiveness of combining BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline
PURPOSE Phase I trial to study the effectiveness of combining BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of BMS-247550 and capecitabine on 2 different schedules in patients with metastatic breast cancer previously treated with a taxane and an anthracycline
Determine the safety profile of this regimen in these patients
Determine preliminarily any antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 2 groups
Group I Patients receive BMS-247550 IV over 3 hours on day 1 and oral capecitabine twice daily on days 1-14
Group II Patients receive BMS-247550 IV over 1 hour on days 1-3 and capecitabine as in group I
Treatment in both groups repeats every 3 weeks for 2-18 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of BMS-247550 and capecitabine until the maximum tolerated dose MTD is determined for each group The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity Additional patients are treated at the MTD
Patients are followed for at least 30 days and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 34-60 patients will be accrued for this study within 8-12 months
Determine the maximum tolerated dose of BMS-247550 and capecitabine on 2 different schedules in patients with metastatic breast cancer previously treated with a taxane and an anthracycline
Determine the safety profile of this regimen in these patients
Determine preliminarily any antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 2 groups
Group I Patients receive BMS-247550 IV over 3 hours on day 1 and oral capecitabine twice daily on days 1-14
Group II Patients receive BMS-247550 IV over 1 hour on days 1-3 and capecitabine as in group I
Treatment in both groups repeats every 3 weeks for 2-18 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of BMS-247550 and capecitabine until the maximum tolerated dose MTD is determined for each group The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity Additional patients are treated at the MTD
Patients are followed for at least 30 days and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 34-60 patients will be accrued for this study within 8-12 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G02-2120 | Registry Identifier | PDQ Physician Data Query | None |
| UCLA-0206011 | None | None | None |
| CDR0000258052 | REGISTRY | None | None |