Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Vinblastine; Vinorelbine

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