A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
- Determine the objective tumor response rate of patients with advanced adenocarcinoma of
the esophagus, gastroesophageal junction, or gastric cardia treated with oxaliplatin
- Determine the time to progression and overall survival of patients treated with this
- Determine the toxic effects of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice
daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of
disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2
additional courses after CR.
Quality of life is assessed at baseline and then every 3 weeks (prior to each course of
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A maximum of 44 patients will be accrued for this study within 26 months.
Masking: Open Label, Primary Purpose: Treatment
Objective tumor response rate
Aminah Jatoi, MD
United States: Federal Government
|Mercy Medical Center - Sioux City||Sioux City, Iowa 51104|
|Siouxland Hematology-Oncology Associates, LLP||Sioux City, Iowa 51101|
|St. Luke's Regional Medical Center||Sioux City, Iowa 51104|
|Sanford Cancer Center at Sanford USD Medical Center||Sioux Falls, South Dakota 57117-5039|
|Medical X-Ray Center, PC||Sioux Falls, South Dakota 57105|
|Avera Cancer Institute||Sioux Falls, South Dakota 57105|