Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00215995
Status:
COMPLETED
Last Update Posted:
2012-01-13
First Post:
2005-09-19
Brief Title:
Cisplatin and Irinotecan Chemotherapy Followed by ZD 1839 Iressa in Patients With Esophageal or Gastric Carcinomas
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Study of Cisplatin and Irinotecan Induction Chemotherapy Followed by ZD 1839 IRESSA in Adult Patients With Surgically Unresectable andor Metastatic Esophageal or Gastric Carcinomas
Status:
COMPLETED
Status Verified Date:
2007-05
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:
This study is for patients with esophageal esophagogastric or gastric cancer that has spread to other parts of the body The purpose of this study is to test the safety and effectiveness of a new experimental drug called ZD 1839 following initial therapy with two other chemotherapy drugs called Irinotecan CPT-11 and Cisplatin
Detailed Description:
This is an open-label non-randomized multicenter Phase II study designed to evaluate tumor response rates in patients with surgically unresectable andor metastatic esophageal esophagogastric and gastric adenocarcinoma or squamous carcinoma Study schema is as follows Patients will receive Irinotecan and Cisplatin on days 1 and 8 every 21 days for a maximum of 6 cycles of therapy This is then followed by ZD 1839 Iressa which is an oral pill taken once daily During the Iressa phase patients will be evaluated every 6 weeks This includes labs CT scans and physical examination The exploratory objective of the study is to examine the correlation between epidermal growth factor receptor EGFR expression and radiographic response to treatment
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 |
|---|---|---|---|
| USFIRB101525 | None | None | None |