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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. Read our disclaimer for details. Identifier: NCT00215462
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 28, 2009
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
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 Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Stomach Cancer Drug: Vinorelbine Phase 2

Detailed Description:
  • 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
Study Start Date : June 2000
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Primary Outcome Measures :
  1. To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.

Secondary Outcome Measures :
  1. To evaluate the toxicities of vinorelbine in this patient population.

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00215462

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
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Principal Investigator: Matthew Kulke, MD Dana-Farber Cancer Institute
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Responsible Party: Matthew Kulke, MD, Dana-Farber Cancer Institute Identifier: NCT00215462    
Other Study ID Numbers: 00-012
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 28, 2009
Last Verified: April 2009
Keywords provided by Dana-Farber Cancer Institute:
gastric adenocarcinoma
esophageal adenocarcinoma
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action