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Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00215462
First received: September 14, 2005
Last updated: April 27, 2009
Last verified: April 2009
History of Changes

September 14, 2005
April 27, 2009
June 2000
August 2005   (final data collection date for primary outcome measure)
To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.
Same as current
Complete list of historical versions of study NCT00215462 on ClinicalTrials.gov Archive Site
To evaluate the toxicities of vinorelbine in this patient population.
Same as current
Not Provided
Not Provided
 
Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

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.
  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • Stomach Cancer
Drug: Vinorelbine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
August 2005
August 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215462
00-012
Yes
Matthew Kulke, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
Principal Investigator: Matthew Kulke, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP