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

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Adenocarcinoma of Esophagus

Adenocarcinoma of Stomach

Adenocarcinoma of GE Junction

Treatments

Drug: 5-fluorouracil

Drug: Doxorubicin

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00165191

98-048

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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