Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423397
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2007-01-16
Brief Title:
Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer
Sponsor:
University of California San Diego
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Pilot Study of Bioimmunotherapy With IRESSA Gefitinib and Pegylated Interferon Alpha-2a for Patients With UnresectableMetastatic Squamous Cell Carcinoma of the Skin
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth PEG-interferon alfa-2a may interfere with the growth of tumor cells and slow the growth of skin cancer Giving gefitinib together with PEG-interferon alfa-2a may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of PEG-interferon alfa-2a when given together with gefitinib and to see how well they work in treating patients with unresectable or metastatic skin cancer
PURPOSE This phase III trial is studying the side effects and best dose of PEG-interferon alfa-2a when given together with gefitinib and to see how well they work in treating patients with unresectable or metastatic skin cancer
Detailed Description:
OBJECTIVES
Determine the tolerability of gefitinib and PEG-interferon alfa-2a in patients with unresectable or metastatic squamous cell carcinoma of the skin
Determine the response rate in patients treated with gefitinib for 1 month
Determine whether the addition of weekly PEG-interferon alfa-2a to ongoing gefitinib improves response rate in these patients
Determine whether PEG-interferon alfa-2a exacerbates rash in patients who have been treated with gefitinib for 1 month
OUTLINE This is a phase I pilot dose de-escalation study of PEG-interferon alfa-2a followed by an open-label phase II study
Phase I Patients receive oral gefitinib alone once daily for 4 weeks Beginning in week 5 patients also receive PEG-interferon alfa-2a subcutaneously once weekly Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of patients receive de-escalating doses of PEG-interferon alfa-2a until a tolerable dose is determined
Phase II Patients receive gefitinib and PEG-interferon alfa-2a at the tolerable dose determined in phase I
PROJECTED ACCRUAL A total of 16 patients will be accrued for this study
Determine the tolerability of gefitinib and PEG-interferon alfa-2a in patients with unresectable or metastatic squamous cell carcinoma of the skin
Determine the response rate in patients treated with gefitinib for 1 month
Determine whether the addition of weekly PEG-interferon alfa-2a to ongoing gefitinib improves response rate in these patients
Determine whether PEG-interferon alfa-2a exacerbates rash in patients who have been treated with gefitinib for 1 month
OUTLINE This is a phase I pilot dose de-escalation study of PEG-interferon alfa-2a followed by an open-label phase II study
Phase I Patients receive oral gefitinib alone once daily for 4 weeks Beginning in week 5 patients also receive PEG-interferon alfa-2a subcutaneously once weekly Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of patients receive de-escalating doses of PEG-interferon alfa-2a until a tolerable dose is determined
Phase II Patients receive gefitinib and PEG-interferon alfa-2a at the tolerable dose determined in phase I
PROJECTED ACCRUAL A total of 16 patients will be accrued for this study
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 |
|---|---|---|---|
| UCSD-051205 | None | None | None |
| ZENECA-IRUSIRES0488 | None | None | None |