Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Condition or disease
Esophageal CancerGastric CancerStomach Cancer
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Prior therapy with vinca alkaloids
Chemotherapy within the past three weeks
Clinically apparent central nervous system metastases or carcinomatous meningitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Head and Neck Neoplasms
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action