This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.
PRIMARY OBJECTIVE: I. To evaluate recurrence-free survival (RFS) in participants with resected pancreatic neuroendocrine tumors (pNETs) randomized to treatment with capecitabine + temozolomide (CAPTEM) compared to observation only. SECONDARY OBJECTIVES: I. To evaluate overall survival (OS) in participants randomized to treatment with CAPTEM compared to observation only. II. To evaluate the safety and tolerability of CAPTEM compared to observation only. BANKING OBJECTIVE: I. To bank specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14 and temozolomide PO once daily (QD) on days 10-14. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo surveillance with no active treatment. After completion of study treatment, patients are followed up every 6 months for 3 years and then annually until 5 years from randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
141
Given PO
Given PO
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
RECRUITINGAnchorage Radiation Therapy Center
Anchorage, Alaska, United States
SUSPENDEDAlaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
RECRUITINGAlaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Recurrence-free survival (RFS)
Distribution of RFS in each arm will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
Time frame: From date of randomization to progression/recurrence or death from any cause, assessed up to 5 years
Overall survival (OS)
Distribution of OS in each arm will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
Time frame: From date of registration to date of death due to any cause, assessed up to 5 years
Incidence of adverse events
Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Time frame: Up to 30 days after completion of treatment
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Alaska Women's Cancer Care
Anchorage, Alaska, United States
RECRUITINGAnchorage Oncology Centre
Anchorage, Alaska, United States
SUSPENDEDKatmai Oncology Group
Anchorage, Alaska, United States
RECRUITINGProvidence Alaska Medical Center
Anchorage, Alaska, United States
RECRUITINGFairbanks Memorial Hospital
Fairbanks, Alaska, United States
ACTIVE_NOT_RECRUITINGBanner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITING...and 438 more locations