Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215202
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2005-09-15
Brief Title:
Phase II Trial of ZD1839 Iressa in Patients With Nonresectable Adrenocortical Carcinoma ACC
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Phase II Trial of ZD1839 Iressa in Patients With Nonresectable Adrenocortical Carcinoma ACC
Status:
COMPLETED
Status Verified Date:
2018-05
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 use of Iressa will result in a greater than 20 response rate in patients with nonresectable adrenocortical cancer who have previously been treated with one other form of systemic therapy either Mitotane or chemotherapy
Detailed Description:
Adrenocortical carcinoma is a rare cancer with an incidence of 15 to 2 per million people in the United States Surgery is the only potentially curative option Current systemic therapy either Mitotane or chemotherapy typically gives response rates of 20 or less This study is designed to see if the newer targeted therapy Iressa may be of benefit for patients with this fatal disease
Patients with nonresectable adrenocortical cancer who have progressed on at least one other form of systemic therapy Mitotane or chemotherapy will be given Iressa 250 mg by mouth daily until disease progression This is a standard two-stage Phase II clinical trial Eighteen patients with measurable disease will be enrolled in the first stage If there is at least one responder then an additional nine patients with measurable disease will be enrolled for a total of 27 patients with measurable disease Up to six patients without measurable disease may be enrolled at any point in this study Iressa will be provided free for all study participants
Patients with nonresectable adrenocortical cancer who have progressed on at least one other form of systemic therapy Mitotane or chemotherapy will be given Iressa 250 mg by mouth daily until disease progression This is a standard two-stage Phase II clinical trial Eighteen patients with measurable disease will be enrolled in the first stage If there is at least one responder then an additional nine patients with measurable disease will be enrolled for a total of 27 patients with measurable disease Up to six patients without measurable disease may be enrolled at any point in this study Iressa will be provided free for all study participants
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