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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Cisplatin; Doxorubicin; Fluorouracil; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE junction or esophagus

• No more than one prior chemotherapy regimen

• ECOG performance status of < or equal to 2

• Life expectancy > 12 weeks

• ANC > 1,500/mm3

• Hemoglobin > 9.0 gm/dl

• Platelets > 100,000/mm3

• SGOT < 3 x ULN

• Total bilirubin < 2.0 mg/dl

• Creatinine < 1.5 mg/dl

Exclusion Criteria:

• Prior cisplatin or doxorubicin as neoadjuvant or adjuvant therapy with in 1 year of study entry

• Clinically apparent central nervous system metastases or carcinomatous meningitis

• Myocardial infarction in the past 6 months

• Major surgery in the past 2 weeks

• Uncontrolled serious medical or psychiatric illness

• Pregnant or lactating women

• Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

• History or clinical evidence of congestive heart failure