Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020189
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2001-07-11
Brief Title:
Flavopiridol in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With RecurrentMetastatic Squamous Cell Carcinoma of the Head and Neck SCCHN
Status:
COMPLETED
Status Verified Date:
2004-08
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 work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or metastatic head and neck cancer
PURPOSE Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or metastatic head and neck cancer
Detailed Description:
OBJECTIVES
Determine the standard response rate complete response and partial response and duration of response in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with flavopiridol
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
Determine the effects of anti-platelet agents aspirin and clopidogrel bisulfate on the pharmacology of flavopiridol in these patients
Determine the effects of prophylactic anticoagulation with anti-platelet agents aspirin and clopidogrel bisulfate on the incidence of flavopiridol-related thrombosis in these patients
OUTLINE Patients receive flavopiridol IV over 1 hour on days 1-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients also receive oral aspirin and clopidogrel bisulfate beginning on day 0 and continuing throughout the study
Patients are followed until death
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 1-3 years
Determine the standard response rate complete response and partial response and duration of response in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with flavopiridol
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
Determine the effects of anti-platelet agents aspirin and clopidogrel bisulfate on the pharmacology of flavopiridol in these patients
Determine the effects of prophylactic anticoagulation with anti-platelet agents aspirin and clopidogrel bisulfate on the incidence of flavopiridol-related thrombosis in these patients
OUTLINE Patients receive flavopiridol IV over 1 hour on days 1-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients also receive oral aspirin and clopidogrel bisulfate beginning on day 0 and continuing throughout the study
Patients are followed until death
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 1-3 years
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T99-0066 | None | None | None |
| NCI-00-C-0128 | None | None | None |
| MB-401 | None | None | None |