Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-01-04 @ 8:51 AM
Study NCT ID:
NCT00057850
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2003-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase I/II Trial of the Epothilone B Analogue BMS 247550 (NSC 710428)/Cisplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2003-04
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:
Phase I/II trial to study the effectiveness of combining BMS-247550 with cisplatin in treating patients who have metastatic or recurrent head and neck cancer. 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.
Detailed Description:
OBJECTIVES:
I. Determine the recommended phase II dose of BMS-247550 when administered with cisplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. (Phase I) II. Determine the toxic effects of this regimen in these patients. III. Determine the response rate, time to progression, and survival of patients treated with this regimen. (Phase II) IV. Determine the pharmacokinetics of this regimen in these patients. V. Correlate selected markers from peripheral blood mononuclear cells and tumor samples with toxicity and response in patients treated with this regimen.
OUTLINE: This is an open-label, dose-escalation study of BMS-247550.
Phase I: Patients receive BMS-247550 IV over 3 hours and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 21 days 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 at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 10 additional patients receive treatment as above at the recommended phase II dose of BMS-247550.
Phase II: Patients receive treatment as in Phase I at the recommended phase II dose of BMS-247550.
I. Determine the recommended phase II dose of BMS-247550 when administered with cisplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. (Phase I) II. Determine the toxic effects of this regimen in these patients. III. Determine the response rate, time to progression, and survival of patients treated with this regimen. (Phase II) IV. Determine the pharmacokinetics of this regimen in these patients. V. Correlate selected markers from peripheral blood mononuclear cells and tumor samples with toxicity and response in patients treated with this regimen.
OUTLINE: This is an open-label, dose-escalation study of BMS-247550.
Phase I: Patients receive BMS-247550 IV over 3 hours and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 21 days 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 at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 10 additional patients receive treatment as above at the recommended phase II dose of BMS-247550.
Phase II: Patients receive treatment as in Phase I at the recommended phase II dose of BMS-247550.
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?: