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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adenocarcinoma of Stomach, Adenocarcinoma of GE Junction, Adenocarcinoma of Esophagus

Intervention / Treatment
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* Drug: Doxorubicin
* Drug: Cisplatin
* Drug: 5-fluorouracil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Doxorubicin|nan|
|Drug: Cisplatin|nan|
|Drug: 5-fluorouracil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety of doxorubicin, cisplatin and 5-fluorouracil when given in combination to treat this patient population |  |  | 
| evaluate the survival of this patient population. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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doxorubicin, cisplatin, 5-fluorouracil, stomach cancer, esophagus cancer