A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for Metastatic Adenocarcinoma of the Lower Esophagus, Gastroesophageal Junction, and Gastric Cardia
- Determine the confirmed tumor response rate in patients with unresectable, metastatic
adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated
with bortezomib, paclitaxel, and carboplatin.
- Determine the time to tumor progression, overall survival, and duration of response in
patients treated with this regimen.
- Determine the adverse events in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3
hours and carboplatin IV over 30 minutes on day 2. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease
progression and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 17
Masking: Open Label, Primary Purpose: Treatment
Confirmed tumor response rate
Aminah Jatoi, MD
United States: Federal Government