Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519077
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2007-08-17
Brief Title:
Phase II Study of Skin Toxicity Dosing of IRESSA Gefitinib in Squamous Cell Carcinoma of the Head and Neck
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Phase II Study of Skin Toxicity Dosing of IRESSA Gefitinib as Monotherapy in Recurrent andor Metastatic Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2016-06
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 purpose of this study is to demonstrate the activity response rate and rate of stable disease of Iressa administered as a single agent escalated to a dose that produces grade 2 skin toxicity in patients with recurrent andor metastatic squamous cell carcinoma of the head and neck SCCHN
Detailed Description:
This open-label multi-institution phase II study evaluated the activity of gefitinib at individually escalated doses up to 750mg to achieve the skin toxicity grade greater than or equal to 2 Patients were started on gefitinib 250mg orally daily for 2 weeks At 2 weeks patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 30 CTC 30 Patients with grade 2 or greater skin toxicity remained on 250 mg daily in patients with grade 0-1 skin toxicity the dose was escalated to 500 mg daily and again to 750 mg daily on next evaluation until grade 2 or greater skin toxicity was developed
The protocol was later amended because of the reported lower efficacy of the 250 mg dose and patients were then started at 500 mg per day There was no further dose escalation beyond 750 mg per day irrespective of the response or grade of skin toxicity Therapy was discontinued upon disease progression unacceptable toxicity death or patients withdrawal of consent Dose interruptions were used as the first approach to managing the toxicity of the patients who experienced grade 3-4 non-hematological toxicities Gefitinib was interrupted for up to a maximum of 14 days until the toxicities dropped to grade 1 or less Adherence to therapy was monitored using drug diaries that were collected at each physician visit and assessed against pill counts
The protocol was later amended because of the reported lower efficacy of the 250 mg dose and patients were then started at 500 mg per day There was no further dose escalation beyond 750 mg per day irrespective of the response or grade of skin toxicity Therapy was discontinued upon disease progression unacceptable toxicity death or patients withdrawal of consent Dose interruptions were used as the first approach to managing the toxicity of the patients who experienced grade 3-4 non-hematological toxicities Gefitinib was interrupted for up to a maximum of 14 days until the toxicities dropped to grade 1 or less Adherence to therapy was monitored using drug diaries that were collected at each physician visit and assessed against pill counts
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