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Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00215462
First Posted: September 22, 2005
Last Update Posted: April 28, 2009
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.
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute
  Purpose
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 Intervention Phase
Esophageal Cancer Gastric Cancer Stomach Cancer Drug: Vinorelbine Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

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

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

Estimated Enrollment: 32
Study Start Date: June 2000
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00215462


Locations
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
Investigators
Principal Investigator: Matthew Kulke, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Matthew Kulke, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00215462     History of Changes
Other Study ID Numbers: 00-012
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: April 28, 2009
Last Verified: April 2009

Keywords provided by Dana-Farber Cancer Institute:
gastric adenocarcinoma
esophageal adenocarcinoma
vinorelbine

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Vinorelbine
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action