Phase II Study of Single Agent Regorafenib in Patients With Advanced/Metastatic Neuroendocrine Tumors
PRIMARY OBJECTIVES:
I. To assess progression-free survival (PFS) in advanced/metastatic in patients with
carcinoid or pancreatic islet cell tumors.
SECONDARY OBJECTIVES:
I. To assess overall survival and response rate in advanced/metastatic poor prognosis in
patients with carcinoid or pancreatic islet cell tumors.
II. To assess the toxicity of patients treated with regorafenib. III. To explore markers of
angiogenesis as they relate to outcome in carcinoid and pancreatic islet cell tumors.
OUTLINE:
Patients receive regorafenib orally (PO) once daily (QD) on days 1-21. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Not recruiting | Neuroendocrine Tumors | Multisite
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 II-R and a Phase III Trial Evaluating Both *Erlotinib (PH II-R) and Chemoradiation (PH III) as Adjuvant Treatment For Patients With Resected Head of Pancreas Adenocarcinoma
PRIMARY OBJECTIVES:
I. To determine whether the addition of erlotinib (erlotinib hydrochloride) to gemcitabine
(gemcitabine hydrochloride) adjuvant chemotherapy shows a signal for improved survival as
compared to gemcitabine alone following R0 or R1 resection of head of pancreas
adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). (Phase
II-R) II. To determine whether the use of concurrent fluoropyrimidine and radiotherapy
following adjuvant gemcitabine hydrochloride-based chemotherapy further enhances survival
for such patients who are without evidence of progressive disease after 5 cycles of
gemcitabine based chemotherapy. (Phase III)
SECONDARY OBJECTIVES:
I. To evaluate disease-free survival of adjuvant chemotherapy followed by radiotherapy and
concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who
are disease free after 5 cycles of adjuvant chemotherapy.
II. To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and
without erlotinib for patients with resected head of pancreas adenocarcinoma.
III. To evaluate adverse events with and without erlotinib for patients with resected head
of pancreas adenocarcinoma.
IV. To evaluate adverse events of adjuvant chemotherapy with or without radiation therapy
and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma
who are disease free after adjuvant chemotherapy.
V. To evaluate preoperative cross-sectional imaging of the primary head of pancreas
adenocarcinoma in order to determine the frequency with which objective criteria of
resectability are present.
VI. To determine if patients reporting low baseline fatigue, as measured by the Functional
Assessment of Chronic Illness Therapy (FACIT)-Fatigue, predicts survival and to explore
correlations between baseline fatigue, as measured by Patient-Reported Outcomes Measurement
Information System (PROMIS), and survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days
1, 8, and 15. Treatment repeats every 28 days for 5 courses in the absence of disease
progression or unacceptable toxicity.
ARM II: Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride
orally (PO) once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the
absence of disease progression or unacceptable toxicity. (NOTE: Phase II-R erlotinib
hydrochloride randomization completed, Arm 2 closed to accrual effective 2/19/2014)
Patients with no disease progression after treatment in arm I or II are then stratified
according to their first randomization treatment arm (arm I vs arm II) and randomized to 1
of 2 additional treatment arms (arm III or IV).
ARM III: Patients receive 1 course of the same treatment that they receive in arm I or II.
ARM IV: Patients receive 1 course of the same treatment that they receive in arm I or II.
Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy
(3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week
for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO
twice daily (BID) 5 days per week or fluorouracil IV continuously for 5.5 weeks or until
radiotherapy is completed.
After completion of study treatment, patients are followed up periodically.
Powered by
SC CTSI