NCT00165191

Doxorubicin, Cisplatin, 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus

A Phase II Study of Doxorubicin, Cisplatin, and 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (planned)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Adenocarcinoma of Stomach
• Adenocarcinoma of GE Junction
• Adenocarcinoma of Esophagus

Interventions

Type	Name	Description
DRUG	Doxorubicin
DRUG	Cisplatin
DRUG	5-fluorouracil

Timeline

• Start date: 1998-08-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2005-09-14
• Last updated: 2009-04-28

Locations

2 sites across 1 country: United States