Ignite Creation Date:
2024-05-05 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006086
Status:
COMPLETED
Last Update Posted:
2010-09-09
First Post:
2000-08-03
Brief Title:
BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2002-09
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 BMS-188797 and carboplatin in treating patients who have advanced nonhematologic cancer
PURPOSE Phase I trial to study the effectiveness of BMS-188797 and carboplatin in treating patients who have advanced nonhematologic cancer
Detailed Description:
OBJECTIVES
Determine the recommended phase II dose based on the maximum tolerated dose of BMS-188797 when administered with carboplatin in patients with advanced nonhematologic malignancies
Assess the dose limiting toxicities and safety of this treatment regimen in these patients
Determine the plasma pharmacokinetics of this treatment regimen in these patients
Determine any antitumor activity of this treatment regimen in these patients
OUTLINE This is a dose escalation study of BMS-188797
Patients receive BMS-188797 IV over 1 hour followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BMS-188797 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities
Patients are followed for 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 35 patients will be accrued for this study over 12 months
Determine the recommended phase II dose based on the maximum tolerated dose of BMS-188797 when administered with carboplatin in patients with advanced nonhematologic malignancies
Assess the dose limiting toxicities and safety of this treatment regimen in these patients
Determine the plasma pharmacokinetics of this treatment regimen in these patients
Determine any antitumor activity of this treatment regimen in these patients
OUTLINE This is a dose escalation study of BMS-188797
Patients receive BMS-188797 IV over 1 hour followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BMS-188797 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities
Patients are followed for 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 35 patients will be accrued for this study over 12 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 |
|---|---|---|---|
| NCI-G00-1825 | None | None | None |
| BMS-CA159-003 | None | None | None |
| MCC-12176 | None | None | None |