Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126555
Status:
COMPLETED
Last Update Posted:
2019-08-30
First Post:
2005-08-02
Brief Title:
Gefitinib in Treating Patients Who Are Undergoing Surgery andor Radiation Therapy for Locally Advanced or Recurrent Squamous Cell Skin Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of ZD1839 and Radiation in Patients With Squamous Cell Carcinoma of the Skin
Status:
COMPLETED
Status Verified Date:
2019-08
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:
The goal of this clinical research study is to learn if giving Iressa Gefitinib or ZD1839 with surgery andor radiation will help to control squamous cell carcinoma of the skin The safety of this treatment will also be studied
Detailed Description:
PRIMARY OBJECTIVES
I Early progression rate progression during ZD1839 induction
II Feasibility of induction ZD1839 for all patients and concomitant ZD1839 with radiotherapy for unresectable patients
III Toxicities of induction ZD1839 for all patients and concomitant ZD1839 with radiotherapy for unresectable patients
SECONDARY OBJECTIVES
I Response clinical responses to induction therapy
II Failures frequency and timing of local and distant failures
III Biomarkers biomarker levels in tumor and normal tissue
TERTIARY OBJECTIVES
I For progressive disease responders patients will be followed for locoregional and distant metastases data
II Feasibility of maintenance ZD1839
III Toxicities of maintenance ZD1839
OUTLINE Patients are assigned to 1 of 2 groups
STRATUM I initially resectable tumor Patients undergo radiotherapy once daily QD 5 days a week for approximately 6-7 weeks Patients also receive gefitinib orally PO QD for up to 12 months
STRATUM II initially unresectable tumor Patients undergo radiotherapy QD 5 days a week for approximately 6-7 weeks Patients also receive concurrent gefitinib PO QD for 6-7 weeks Patients then undergo surgery After surgery patients receive gefitinib PO QD for up to 12 months
After completion of study treatment patients are followed up for up to 5 years
I Early progression rate progression during ZD1839 induction
II Feasibility of induction ZD1839 for all patients and concomitant ZD1839 with radiotherapy for unresectable patients
III Toxicities of induction ZD1839 for all patients and concomitant ZD1839 with radiotherapy for unresectable patients
SECONDARY OBJECTIVES
I Response clinical responses to induction therapy
II Failures frequency and timing of local and distant failures
III Biomarkers biomarker levels in tumor and normal tissue
TERTIARY OBJECTIVES
I For progressive disease responders patients will be followed for locoregional and distant metastases data
II Feasibility of maintenance ZD1839
III Toxicities of maintenance ZD1839
OUTLINE Patients are assigned to 1 of 2 groups
STRATUM I initially resectable tumor Patients undergo radiotherapy once daily QD 5 days a week for approximately 6-7 weeks Patients also receive gefitinib orally PO QD for up to 12 months
STRATUM II initially unresectable tumor Patients undergo radiotherapy QD 5 days a week for approximately 6-7 weeks Patients also receive concurrent gefitinib PO QD for 6-7 weeks Patients then undergo surgery After surgery patients receive gefitinib PO QD for up to 12 months
After completion of study treatment patients are followed up for up to 5 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 |
|---|---|---|---|
| 2004-0204 | None | None | None |