Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

Study Overview
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Brief Summary
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The purpose of this study is to collect anti-tumor activity of vinorelbine when given to patients with esophageal or gastric tumors. We will also collect information on the toxicities of vinorelbine in these patients.

Detailed Description
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Patients will receive vinorelbine intravenously once per week for eight weeks. These treatments will be repeated after the initial eight weeks as long as the patient continues to receive benefit from the treatment. If the patient experiences significant toxicities, the dose may be reduced or the chemotherapy may be discontinued. Before beginning treatment and during therapy, routine laboratory tests, scans and x-rays will be done to check the body's response to treatment. A physical exam will be done at the start of the study and before each course of treatment. Scans will be done after eight weeks of therapy. Patients will remain on this study as long as their disease does not become worse or they do not experience severe side effects.

Official Title
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A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

Conditions
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Esophageal Cancer, Gastric Cancer, Stomach Cancer

Intervention / Treatment
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* Drug: Vinorelbine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Locally unresectable or metastatic esophageal adenocarcinoma. Locally unresectable or metastatic gastric adenocarcinoma. Only patients with measurable tumors are eligible. No more than one prior chemotherapy regimen ECOG performance status of 0-1 Life expectancy of > 12 weeks Greater than or equal to 1,200 calorie/day intake ANC > 1,500/mm3 AST < 3 x ULN Total bilirubin < 2.0 ng/dl Platelets > 100,000/mm3 Serum creatinine < 2.0 mg/dl Exclusion Criteria: Prior therapy with vinca alkaloids Chemotherapy within the past three weeks Clinically apparent central nervous system metastases or carcinomatous meningitis Peripheral neuropathy > 1

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: Vinorelbine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the toxicities of vinorelbine in this patient population. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vinorelbine, gastric adenocarcinoma, esophageal adenocarcinoma