Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215462
Status:
COMPLETED
Last Update Posted:
2009-04-28
First Post:
2005-09-14
Brief Title:
Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
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 anti-tumor activity of vinorelbine when given to patients with esophageal or gastric tumors We will also collect information on the toxicities of vinorelbine in these patients
Detailed Description:
Patients will receive vinorelbine intravenously once per week for eight weeks These treatments will be repeated after the initial eight weeks as long as the patient continues to receive benefit from the treatment If the patient experiences significant toxicities the dose may be reduced or the chemotherapy may be discontinued
Before beginning treatment and during therapy routine laboratory tests scans and x-rays will be done to check the bodys response to treatment A physical exam will be done at the start of the study and before each course of treatment Scans will be done after eight weeks of therapy
Patients will remain on this study as long as their disease does not become worse or they do not experience severe side effects
Before beginning treatment and during therapy routine laboratory tests scans and x-rays will be done to check the bodys response to treatment A physical exam will be done at the start of the study and before each course of treatment Scans will be done after eight weeks of therapy
Patients will remain on this study as long as their disease does not become worse or they do not experience severe side effects
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