Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003327
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
1999-11-01
Brief Title:
Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Paclitaxel TAXOL Administered as a Weekly One Hour Infusion in Previously Treated Patients With Advanced Head and Neck Cancer
Status:
UNKNOWN
Status Verified Date:
2001-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or refractory head and neck cancer
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or refractory head and neck cancer
Detailed Description:
OBJECTIVES I Determine the objective response rate of paclitaxel as salvage therapy in patients with recurrent or refractory head and neck cancer II Evaluate the safety of paclitaxel in this patient population III Assess the overall survival and quality of life in these patients
OUTLINE This is an open label multicenter nonrandomized study Patients receive intravenous paclitaxel over 1 hour weekly Each course consists of four weeks Patients receive treatment until disease progression or unacceptable toxic effects are observed Patients are followed every 2 months for the first year then every 4 months until completion of treatment and then every 3 months until death Patients complete a quality of life questionnaire prior to each of the first 6 courses then every 2 courses thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
OUTLINE This is an open label multicenter nonrandomized study Patients receive intravenous paclitaxel over 1 hour weekly Each course consists of four weeks Patients receive treatment until disease progression or unacceptable toxic effects are observed Patients are followed every 2 months for the first year then every 4 months until completion of treatment and then every 3 months until death Patients complete a quality of life questionnaire prior to each of the first 6 courses then every 2 courses thereafter
PROJECTED ACCRUAL A total of 60 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 |
|---|---|---|---|
| NCI-V98-1415 | None | None | None |
| THERADEX-B97-5250 | None | None | None |
| BMS-TAXMEN05 | None | None | None |