search
Back to results

Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

Primary Purpose

Esophageal Cancer, Gastric Cancer, Stomach Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vinorelbine
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring gastric adenocarcinoma, esophageal adenocarcinoma, vinorelbine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Outcomes

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.

Full Information

First Posted
September 14, 2005
Last Updated
April 27, 2009
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00215462
Brief Title
Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
Official Title
A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer, Stomach Cancer
Keywords
gastric adenocarcinoma, esophageal adenocarcinoma, vinorelbine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Primary Outcome Measure Information:
Title
To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.
Secondary Outcome Measure Information:
Title
To evaluate the toxicities of vinorelbine in this patient population.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Kulke, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

We'll reach out to this number within 24 hrs