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
A Phase 2 Study of the PARP Inhibitor Olaparib (AZD2281) in IDH1 and IDH2 Mutant Advanced Solid Tumors
PRIMARY OBJECTIVE:
I. To estimate the overall response rates of olaparib in subjects with recurrent/progressive
IDH1/2-mutant solid tumors, who will be recruited to 3 cohorts: a. glioma, b.
cholangiocarcinoma, c. other solid malignant tumors.
SECONDARY OBJECTIVES:
I. To estimate the distribution of progression free survival (PFS) of olaparib in adults with
recurrent/progressive IDH1/2-mutant glioma and cholangiocarcinoma.
II. To estimate the overall survival (OS) in adults with recurrent/progressive IDH1/2- mutant
glioma and cholangiocarcinoma.
III. To determine the duration of response in adults with recurrent/progressive IDH1/2-mutant
glioma, cholangiocarcinoma or other solid malignant tumors.
IV. To confirm the safety and tolerability of olaparib monotherapy.
EXPLORATORY OBJECTIVES:
I. To describe 2HG concentration in plasma by mass spectrometry at baseline and at specific
timepoints and correlate with treatment response.
II. To describe 2HG levels in tumor biopsies from prior to the beginning of treatment and at
specific timepoints and correlate with treatment response.
III. To evaluate in tumor biopsies and in liquid biopsies performed at baseline and at
specific timepoints if co-occurring alterations detected via multiplexed immunofluorescence,
mass cytometry (CyTOF)-imaging mass cytometry (IMC), ribonucleic acid (RNA) sequencing and/or
deoxyribonucleic acid (DNA) sequencing can be associated with differential levels of 2HG
production, treatment response and resistance.
OUTLINE:
Patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
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