A Phase II Study of PS-341 Alone or in Combination With Irinotecan in Patients With Adenocarcinoma of the Gastroesophageal Junction (GEJ) or Stomach
I. To determine the response rate for the combination of irinotecan and PS 341 in patients
with previously untreated adenocarcinoma of the stomach or GEJ.
II. To determine the response rate for PS341 in patients with previously treated
adenocarcinoma of the stomach or GEJ.
III. To determine the toxicities and recovery from toxicities for patients receiving PS 341
alone or in combination with irinotecan IV. To perform GeneChip analysis on biopsy specimens
prior to and subsequent to treatment with PS341 to determine changes in patterns of gene
OUTLINE: Patients are stratified (stratum 2 closed to accrual as of 9/19/2006) according to
prior chemotherapy for advanced disease (yes vs no).
STRATUM 1 (Previously untreated patients): Patients receive bortezomib IV over 3-5 seconds
on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
STRATUM 2 (Previously treated patients) (closed to accrual as of 9/19/2006): Patients
receive bortezomib as in stratum 1.
In both strata, courses repeat every 21 days in the absence of disease progression or
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
True response rate evaluated for the combination of irinotecan and PS341 by Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 6 years
Montefiore Medical Center
United States: Food and Drug Administration
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