A Randomized Phase II Trial of PS-341 and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
I. Compare the objective response rate in previously untreated patients with metastatic
pancreatic adenocarcinoma treated with bortezomib with or without gemcitabine.
II. Compare the toxicity of these regimens in these patients. III. Compare the
progression-free, 6-month, and overall survival of patients treated with these regimens.
IV. Compare the change in overall quality of life (QOL) and in subcomponents of QOL of
patients after treatment with 2 consecutive courses of these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1of 2 treatment arms.
ARM I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients
with progressive disease crossover to arm II.
ARM II: Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1
Courses in both arms repeat every 3 weeks in the absence of disease progression or
Quality of life (QOL) is assessed at baseline and before courses 2 and 4. Patients who
crossover to arm II from arm I complete QOL questionnaires before the first 2 courses of arm
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed tumor response (CR, PR) rate in 2 consecutive courses within 6 months (Arm I)
An evaluable patient will be classified as a treatment 'success' if they have a confirmed tumor response (CR, PR). The proportion of successes will be estimated by the total number of evaluable patients. 95% confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
Up to 6 months
North Central Cancer Treatment Group
United States: Food and Drug Administration
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