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Completed

NCT Number: NCT00215462

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vinorelbine

Drug

Primary outcomes

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

Secondary outcomes

  1. To evaluate the toxicities of vinorelbine in this patient population.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Apr 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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