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

Recruiting now · Phase 2

Conditions studied: Metastatic Malignant Neoplasm in the Liver, Pancreatic Neuroendocrine Tumor, Stage I Pancreatic Neuroendocrine Tumor AJCC v8, Stage II Pancreatic Neuroendocrine Tumor AJCC v8, Stage III Pancreatic Neuroendocrine Tumor AJCC v8

In brief

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.

Key facts

Study ID

NCT05040360

Run by

SWOG Cancer Research Network

People needed

141

Starts

2022-05-05

Expected to finish

2027-03-31

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Pain from primary tumor prior to surgical resection
• Pancreatitis
• 2 points; primary pancreas tumor size > 2 cm
• 1 point; Ki-67 3% to 20%
• 1 point; lymph node positivity = 1
• 6 points; Ki-67 21% to 55%
• Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection
• Participants must have recovered from effects of surgery as determined by the treating investigator
• Participants must be >= 18 years old
• Participants must have Zubrod performance status of 0-2
• Participants must have a complete medical history and physical exam within 28 days prior to registration
• Leukocytes >= 3 x 10\^3/uL (within 28 days prior to registration)
• Absolute neutrophil count >= 1.5 x 10\^3/uL (within 28 days prior to registration)
• Platelets >= 100 x 10\^3/uL (within 28 days prior to registration)
• Total bilirubin =< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN (within 28 days prior to registration)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to registration)
• Serum creatinine =< 1.5 x institutional ULN (within 28 days prior to registration)

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
• Participants must not have active or uncontrolled infection
• Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator
• Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen

Where it is running

• Mercy Cancer Center - Elk Grove — Elk Grove, California, United States (enrolling)
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States (enrolling)
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States (enrolling)
• Alaska Women's Cancer Care — Anchorage, Alaska, United States (enrolling)
• Keck Medicine of USC Huntington Beach — Huntington Beach, California, United States (enrolling)
• Katmai Oncology Group — Anchorage, Alaska, United States (enrolling)
• Providence Alaska Medical Center — Anchorage, Alaska, United States (enrolling)
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States (enrolling)
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
• Kingman Regional Medical Center — Kingman, Arizona, United States (enrolling)
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States (enrolling)
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States (enrolling)
• Banner University Medical Center - Tucson — Tucson, Arizona, United States (enrolling)
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States (enrolling)
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States (enrolling)
• CARTI Cancer Center — Little Rock, Arkansas, United States (enrolling)
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States (enrolling)
• PCR Oncology — Arroyo Grande, California, United States (enrolling)
• Tower Cancer Research Foundation — Beverly Hills, California, United States (enrolling)
• Keck Medicine of USC Buena Park — Buena Park, California, United States (enrolling)
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States (enrolling)
• Mercy Cancer Center - Carmichael — Carmichael, California, United States (enrolling)
• Mercy San Juan Medical Center — Carmichael, California, United States (enrolling)
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States (enrolling)
• Keck Medicine of USC Koreatown — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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