Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062387
Status:
TERMINATED
Last Update Posted:
2013-06-03
First Post:
2003-06-05
Brief Title:
Perifosine 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 Study Of Perifosine In Patients With Recurrent Or Metastatic Head And Neck Cancer
Status:
TERMINATED
Status Verified Date:
2004-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent or metastatic head and neck cancer Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the antitumor activity of perifosine in patients with recurrent or metastatic squamous cell head and neck cancer
II Determine the time to progression and overall survival of patients treated with this drug
III Determine the toxicity of this drug in these patients IV Determine the pharmacodynamics of this drug in these patients V Assess the usefulness of biomarkers in predicting response and other outcome parameters in patients treated with this drug
VI Assess the quality of life of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral perifosine 4 times daily on days 1 and 2 and once daily on days 3-28 during course 1 Patients receive oral perifosine once daily on days 1-28 for all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline weekly during the first month every 28 days after the first month and then at study withdrawal
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 22-46 patients will be accrued for this study within 2 years
I Determine the antitumor activity of perifosine in patients with recurrent or metastatic squamous cell head and neck cancer
II Determine the time to progression and overall survival of patients treated with this drug
III Determine the toxicity of this drug in these patients IV Determine the pharmacodynamics of this drug in these patients V Assess the usefulness of biomarkers in predicting response and other outcome parameters in patients treated with this drug
VI Assess the quality of life of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral perifosine 4 times daily on days 1 and 2 and once daily on days 3-28 during course 1 Patients receive oral perifosine once daily on days 1-28 for all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline weekly during the first month every 28 days after the first month and then at study withdrawal
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 22-46 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| CDR0000304740 | REGISTRY | PDQ Physician Data Query | None |
| UCCRC-12198A | None | None | None |
| NCI-5938 | None | None | None |