A Phase II Study of Doxorubicin, Cisplatin, and 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
- 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 body's 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the activity of doxorubicin, cisplatin and continuous infusion of 5-fluorouracil in patients with measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE junction, or esophagus.
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|