Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017498
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2001-06-06
Brief Title:
Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck
Status:
COMPLETED
Status Verified Date:
2012-09
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent or metastatic adenoid cystic cancer of the head and neck
PURPOSE Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent or metastatic adenoid cystic cancer of the head and neck
Detailed Description:
OBJECTIVES
Assess the therapeutic activity of gemcitabine in terms of objective response and duration of response in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck
Determine the acute toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 Treatment repeats every 21 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 12 weeks until disease progression and then every 6 months thereafter
PROJECTED ACCRUAL A total of 16-29 patients will be accrued for this study
Assess the therapeutic activity of gemcitabine in terms of objective response and duration of response in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck
Determine the acute toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 Treatment repeats every 21 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 12 weeks until disease progression and then every 6 months thereafter
PROJECTED ACCRUAL A total of 16-29 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 |
|---|---|---|---|
| EORTC-24982 | None | None | None |