Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital Beth Israel Deaconess Medical Center
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00215462

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 II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer

Drug Information available for: Vinorelbine Vinorelbine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215462

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

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:	Dana-Farber Cancer Institute ( Matthew Kulke, MD )
Study ID Numbers:	00-012
Study First Received:	September 14, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00215462
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

gastric adenocarcinoma
esophageal adenocarcinoma
vinorelbine

Study placed in the following topic categories:

Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Stomach cancer
Carcinoma
Vinorelbine
Digestive System Diseases

Stomach Diseases
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Esophageal neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents

Therapeutic Uses
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009