A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.
Matthew Kulke, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|