Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052754
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2003-01-24
Brief Title:
Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
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 Of Iressa ZD 1839 In Locally Advanced AndOr Metastatic Synovial Sarcoma Expressing HER1EGFR1
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 Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of synovial sarcoma
PURPOSE Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma
PURPOSE Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma
Detailed Description:
OBJECTIVES
Determine the therapeutic activity of gefitinib in terms of progression-free rate in patients with locally advanced or metastatic synovial sarcoma expressing HER1
Determine the toxicity of this drug in these patients
Determine the objective response in terms of time to onset and duration of response in patients treated with this drug
Determine the overall survival of patients treated with this drug
OUTLINE This is a non-randomized multicenter study
Patients receive oral gefitinib twice daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 14-44 patients will be accrued for this study within 18 months
Determine the therapeutic activity of gefitinib in terms of progression-free rate in patients with locally advanced or metastatic synovial sarcoma expressing HER1
Determine the toxicity of this drug in these patients
Determine the objective response in terms of time to onset and duration of response in patients treated with this drug
Determine the overall survival of patients treated with this drug
OUTLINE This is a non-randomized multicenter study
Patients receive oral gefitinib twice daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 14-44 patients will be accrued for this study within 18 months
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-62022 | None | None | None |