Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-03 @ 6:58 PM
Study NCT ID:
NCT00043095
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
2002-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
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?: