Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215462
• Other study ID #: 00-012
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2005
• Last updated: April 27, 2009
• Start date: June 2000
• Est. completion date: August 2005

Study information

• Verified date: April 2009
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Cancer
• Stomach Neoplasms

Intervention

Drug:
• Vinorelbine

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.
Secondary	To evaluate the toxicities of vinorelbine in this patient population.