Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma|
- To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.
- To evaluate the toxicities of vinorelbine in this patient population.
|Study Start Date:||June 2000|
|Study Completion Date:||August 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
- 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 body's 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.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Matthew Kulke, MD||Dana-Farber Cancer Institute|