Status:
COMPLETED
Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 i...
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 fro...
Eligibility Criteria
Inclusion
- 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
- Prior therapy with vinca alkaloids
- Chemotherapy within the past three weeks
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Peripheral neuropathy \> 1
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00215462
Start Date
June 1 2000
End Date
August 1 2005
Last Update
April 28 2009
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115