Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006018
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2000-07-05
Brief Title:
Paclitaxel and BMS-214662 in Treating Patients With Advanced Solid Tumors
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Study of BMS-214662 and Paclitaxel in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2010-06
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 paclitaxel and BMS-214662 in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of paclitaxel and BMS-214662 in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of BMS-214662 in combination with paclitaxel in patients with advanced solid tumors II Determine the safety and tolerability of this regimen in these patients III Determine the pharmacokinetics of this treatment regimen in this patient population IV Determine the pharmacodynamic effects of this treatment regimen in serial tumor biopsies in these patients V Determine the cytotoxicity of this treatment regimen in these patients
OUTLINE This is a dose-escalation study of BMS-214662 Patients receive paclitaxel IV over 3 hours on day 1 and BMS-214662 IV over 1 hour on day 3 of course 1 For all subsequent courses patients receive paclitaxel IV over 3 hours followed 30 minutes later by BMS-214662 IV over 1 hour on day 1 Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or objectively responding disease receive additional therapy at the investigators discretion Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients are followed every 4 weeks
PROJECTED ACCRUAL A maximum of 18-21 patients will be accrued for this study within 12-15 months
OUTLINE This is a dose-escalation study of BMS-214662 Patients receive paclitaxel IV over 3 hours on day 1 and BMS-214662 IV over 1 hour on day 3 of course 1 For all subsequent courses patients receive paclitaxel IV over 3 hours followed 30 minutes later by BMS-214662 IV over 1 hour on day 1 Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or objectively responding disease receive additional therapy at the investigators discretion Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients are followed every 4 weeks
PROJECTED ACCRUAL A maximum of 18-21 patients will be accrued for this study within 12-15 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-290 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| U01CA062502 | NIH | None | None |
| P30CA043703 | NIH | None | None |
| CWRU-4Y99 | None | None | None |