Gastric Cancer Clinical Trial
Official title:
A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin,
work in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may
kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with
fluorouracil and leucovorin works in treating patients with metastatic or unresectable
stomach cancer.
OBJECTIVES:
Primary
- Determine response in patients with previously treated metastatic or unresectable
gastric or gastroesophageal junction adenocarcinoma treated with bortezomib,
fluorouracil, and leucovorin calcium.
Secondary
- Determine time to progression and overall survival of patients treated with this
regimen.
- 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
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