Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068367
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2003-09-10
Brief Title:
S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
USCanada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors Phase II
Status:
COMPLETED
Status Verified Date:
2017-10
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 Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
PURPOSE This phase II trial is studying how well erlotinib works in treating patients with unresectable or metastatic malignant peripheral nerve sheath tumor
PURPOSE This phase II trial is studying how well erlotinib works in treating patients with unresectable or metastatic malignant peripheral nerve sheath tumor
Detailed Description:
OBJECTIVES
Determine response confirmed complete and partial in patients with unresectable or metastatic malignant peripheral nerve sheath tumor when treated with erlotinib
Determine the qualitative and quantitative toxic effects of this drug in these patients
Correlate preliminarily indicators of epidermal growth factor receptor EGFR function eg expression phosphorylation or markers of signal transduction downstream of EGFR with response and progression-free and overall survival in patients treated with this drug
Determine the feasibility of accruing these patients in the cooperative group setting
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients who achieve at least a confirmed partial response and become resectable undergo surgical resection with or without radiotherapy and then receive 2 additional courses of erlotinib Patients with responding disease who do not become resectable continue erlotinib as above Patients achieving a complete response CR receive 2 additional courses of erlotinib beyond the CR
Patients are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
Determine response confirmed complete and partial in patients with unresectable or metastatic malignant peripheral nerve sheath tumor when treated with erlotinib
Determine the qualitative and quantitative toxic effects of this drug in these patients
Correlate preliminarily indicators of epidermal growth factor receptor EGFR function eg expression phosphorylation or markers of signal transduction downstream of EGFR with response and progression-free and overall survival in patients treated with this drug
Determine the feasibility of accruing these patients in the cooperative group setting
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients who achieve at least a confirmed partial response and become resectable undergo surgical resection with or without radiotherapy and then receive 2 additional courses of erlotinib Patients with responding disease who do not become resectable continue erlotinib as above Patients achieving a complete response CR receive 2 additional courses of erlotinib beyond the CR
Patients are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 20-40 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0330 | OTHER | None | None |