Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022529
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2001-08-10
Brief Title:
BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Intravenous BMS-214662 FTI NSC 710086 and Herceptin NSC 688097 Weekly in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of BMS-214662 plus trastuzumab in treating patients who have advanced solid tumors Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and recommended phase II dose of BMS-214662 when combined with trastuzumab Herceptin in patients with advanced solid tumors
II Determine the dose-limiting toxic effects of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of this regimen in these patients Ii Determine in a preliminary manner the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of BMS-214662
Patients receive BMS-214662 IV over 1 hour on days 2 8 15 and 22 and trastuzumab Herceptin IV over 30-90 minutes on days 1 8 15 and 22 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
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 Once the MTD is determined additional patients are accrued to receive treatment with BMS-214662 and trastuzumab at the recommended phase II dose
PROJECTED ACCRUAL A total of 3-28 patients will be accrued for this study
I Determine the maximum tolerated dose and recommended phase II dose of BMS-214662 when combined with trastuzumab Herceptin in patients with advanced solid tumors
II Determine the dose-limiting toxic effects of this regimen in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of this regimen in these patients Ii Determine in a preliminary manner the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of BMS-214662
Patients receive BMS-214662 IV over 1 hour on days 2 8 15 and 22 and trastuzumab Herceptin IV over 30-90 minutes on days 1 8 15 and 22 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
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 Once the MTD is determined additional patients are accrued to receive treatment with BMS-214662 and trastuzumab at the recommended phase II dose
PROJECTED ACCRUAL A total of 3-28 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000068828 | REGISTRY | PDQ Physician Data Query | None |
| FCCC-01013 | None | None | None |