Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

Phase 2

Completed

• Conditions: Esophageal Cancer; Gastric Cancer; Stomach Cancer

• Registration Number: NCT00215462
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study Start: 2000-06
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-27
• Last Update Posted: 2009-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To evaluate the toxicities of vinorelbine in this patient population.

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States