Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

Completed · Phase 2

Conditions studied: Esophageal Cancer, Gastric Cancer, Stomach Cancer

In brief

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.

Key facts

Study ID

NCT00215462

Run by

Dana-Farber Cancer Institute

People needed

32

Starts

2000-06-01

Expected to finish

2005-08-01

Last updated by the study team

2009-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior therapy with vinca alkaloids
• Chemotherapy within the past three weeks
• Clinically apparent central nervous system metastases or carcinomatous meningitis
• Peripheral neuropathy > 1

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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