Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043095
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
2002-08-05
Brief Title:
BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of BMS 247550 NSC 710428 and Gemcitabine in Patients With Advanced Solid Tumor Malignancies
Status:
COMPLETED
Status Verified Date:
2005-04
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 I trial to study the effectiveness of combining BMS-247550 with gemcitabine in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combining BMS-247550 with gemcitabine in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose dose-limiting toxicity and safety of BMS-247550 when combined with gemcitabine in patients with advanced solid tumors
Determine the plasma pharmacokinetics of this regimen in this patient population
Assess preliminarily any antitumor activity of this regimen in this patient population
OUTLINE This is a dose-escalation study of BMS-247550
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by BMS-247550 IV over 3 hours on day 8 The order of chemotherapy drug administration on day 8 is reversed during the second course only Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 9 patients total are treated at the MTD
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study
Determine the maximum tolerated dose dose-limiting toxicity and safety of BMS-247550 when combined with gemcitabine in patients with advanced solid tumors
Determine the plasma pharmacokinetics of this regimen in this patient population
Assess preliminarily any antitumor activity of this regimen in this patient population
OUTLINE This is a dose-escalation study of BMS-247550
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by BMS-247550 IV over 3 hours on day 8 The order of chemotherapy drug administration on day 8 is reversed during the second course only Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 9 patients total are treated at the MTD
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study
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-5696 | None | None | None |
| MSKCC-02012 | None | None | None |