Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165464
Status:
COMPLETED
Last Update Posted:
2009-04-28
First Post:
2005-09-09
Brief Title:
Taxotere Cisplatin and Irinotecan CPT-11 for Esophagogastric Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Trial of Taxotere Cisplatin and Irinotecan in Advanced Esophageal and Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2009-04
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 is a phase II study of taxotere cisplatin and irinotecan CPT-11 used in combination to treat metastatic esophageal and gastric cancer in an effort to see what effects good and bad the combination may have on the patients cancer
Detailed Description:
Taxotere cisplatin and irinotecan will be administered to the patient once weekly for 2 weeks followed by a one week rest period 1 cycle is 3 weeks
Patients will also receive corticosteroids intravenous hydration and anti-emetic therapy prior to each treatment
A physical exam and bloodwork will be done each week of the treatment and every 2 cycles reassessment of the tumor by the same imaging method to determine the baseline size will be conducted
Patients will remain on the study unless disease progression or intolerable toxicity occur
Patients will also receive corticosteroids intravenous hydration and anti-emetic therapy prior to each treatment
A physical exam and bloodwork will be done each week of the treatment and every 2 cycles reassessment of the tumor by the same imaging method to determine the baseline size will be conducted
Patients will remain on the study unless disease progression or intolerable toxicity occur
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