Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00215462

Collaborator

Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other), Beth Israel Deaconess Medical Center (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Gastric Cancer Stomach Cancer	Drug: Vinorelbine	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2000

Actual Primary Completion Date :

Aug 1, 2005

Actual Study Completion Date :

Aug 1, 2005

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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