A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma
- Determine response in patients with previously treated metastatic or unresectable
gastric or gastroesophageal junction adenocarcinoma treated with bortezomib,
fluorouracil, and leucovorin calcium.
- Determine time to progression and overall survival of patients treated with this
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. One hour after
completion of bortezomib, patients receive leucovorin calcium IV and fluorouracil IV
followed by fluorouracil IV continuously over 46 hours on days 1 and 15. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Response rate as measured by RECIST every 8 weeks
Heinz-Josef Lenz, MD
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|University of California Davis Cancer Center||Sacramento, California 95817|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15236|
|City of Hope Medical Group||Pasadena, California 91105|