A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors
PRIMARY OBJECTIVES:
I. To evaluate progression-free survival (PFS) associated with temozolomide alone or
temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors.
SECONDARY OBJECTIVES:
I. To evaluate response rates (RR) associated with temozolomide alone or temozolomide and
capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors.
II. To evaluate overall survival (OS) associated with temozolomide alone or temozolomide and
capecitabine in patients with advanced pancreatic neuroendocrine tumors.
III. To evaluate the toxicity associated with temozolomide alone or temozolomide and
capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors.
IV. To evaluate the usefulness of methyl guanine methyltransferase (MGMT) status (by
immunohistochemistry [IHC] and promoter methylation) for predicting response in pancreatic
neuroendocrine tumor patients treated with either temozolomide or temozolomide and
capecitabine.
V. To bank radiology images for evaluation of quality, reproducibility, and compliance with
computed tomography (CT) methodology.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment
repeats every 28 days for up to 13 courses in the absence of disease progression or
unacceptable toxicity.
ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO
QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
and then every 6 months for 3 years.
Not recruiting | Neuroendocrine Tumors | Multisite
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