Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma

NCT00215462 | Completed Phase 2 DMC

• 1 other identifier: 00-012
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophageal Cancer; Gastric Cancer; Stomach Cancer

Keywords

gastric adenocarcinoma; esophageal adenocarcinoma; vinorelbine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• To evaluate the toxicities of vinorelbine in this patient population.

Interventions

Vinorelbine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Matthew Kulke, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 2000
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: April 28, 2009

Record last verified: 2009-04

Locations

US (2)