RecruitingMetastatic Malignant Neoplasm in the LiverPancreatic Neuroendocrine TumorStage I Pancreatic Neuroendocrine Tumor AJCC v8

Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

Eligible age

18+ yrs

Accepts

All genders

Locations

41 states

Healthy volunteers

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About this study

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.

Sponsor: SWOG Cancer Research Network

You may qualify if…

✓ Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 120 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam
✓ Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report
✓ Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be \>= 3% and =\< 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and/or the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria
✓ Participants with localized resected pNETS must have a Zaidi score of \>= 3 derived by the following factors and points:
✓ 1 point; symptomatic tumor defined as one of the following:
✓ Gastrointestinal bleed
✓ Jaundice
✓ Gastrointestinal obstruction

You may not qualify if…

✕ Participants must not have unresected or unablated metastatic disease
✕ Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis
✕ Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted
✕ Participants must not have received somatostatin analogs after surgery
✕ Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed
✕ Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
✕ Participants must not have known absorption issues that would limit the ability to absorb study agents
✕ Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration