About this trial

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.

Eligibility criteria

Qualifiers

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

Gastrointestinal bleed

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Capecitabine
  • Temozolomide

Treatment groups

141 Participants
are divided into 2 treatment groups

Locations

448
Mexico
Instituto Nacional De Cancerologia de Mexico14080, Mexico CityTlalpan, Mexico
United States
Alaska
Alaska Breast Care and Surgery LLC99508, Anchorage United States
Alaska Oncology and Hematology LLC99508, Anchorage United States
Alaska Women's Cancer Care99508, Anchorage United States

Sponsors and collaborators

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator