Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057850
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2003-04-07
Brief Title:
BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial of the Epothilone B Analogue BMS 247550 NSC 710428Cisplatin 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 III 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:
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 |
|---|---|---|---|
| CDR0000276716 | REGISTRY | PDQ Physician Data Query | None |
| UPCC-04302 | None | None | None |
| NCI-5787 | None | None | None |