Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165191
Status:
COMPLETED
Last Update Posted:
2009-04-28
First Post:
2005-09-09
Brief Title:
Doxorubicin Cisplatin 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Doxorubicin Cisplatin and 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
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:
The purpose of this study is to collect information on the anti-tumor activity of the combination doxorubicin cisplatin and 5-fluorouracil when given to patients with advanced esophageal or gastric adenocarcinoma We will also be collecting information about the side effects and safety of this combination
Detailed Description:
Patients will receive cisplatin and doxorubicin intravenously once every 3 weeks In addition to cisplatin and doxorubicin patients will receive 5-fluorouracil intravenously as a continuous infusion for the duration of the study In order to do this patients will receive an infusion pump that can be carried with them Treatment cycles will be repeated every 21 days for a maximum of 8 cycles
Prior to enrollment in this study and while the patient is receiving the therapy routine blood tests and x-ryas including chest x-rays and CT scans will be performed to check the bodys response to the treatment Blood tests will be checked once a week and chest x-rays and CT scans will be checked every 6 weeks
Patients with progressive disease or intolerable side effects will be removed from the study Patients with stable disease or tumor response will continue therapy for a maximum of 8 cycles
Prior to enrollment in this study and while the patient is receiving the therapy routine blood tests and x-ryas including chest x-rays and CT scans will be performed to check the bodys response to the treatment Blood tests will be checked once a week and chest x-rays and CT scans will be checked every 6 weeks
Patients with progressive disease or intolerable side effects will be removed from the study Patients with stable disease or tumor response will continue therapy for a maximum of 8 cycles
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