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Official Title
Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors
Phase
Phase 2
Sponsor
SWOG Cancer Research Network
Enrollment
141
Timeline
May 2022 → Mar 2027
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.
Eligibility Criteria
Inclusion Criteria
- 1Participants 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
- 2Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report
- 3Ki-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
- 4Participants with localized resected pNETS must have a Zaidi score of \>= 3 derived by the following factors and points:
- 51 point; symptomatic tumor defined as one of the following:
- 6Gastrointestinal bleed
- 7Jaundice
- 8Gastrointestinal obstruction
- 9Pain from primary tumor prior to surgical resection
- 10Pancreatitis
- 112 points; primary pancreas tumor size \> 2 cm
- 121 point; Ki-67 3% to 20%
- 131 point; lymph node positivity = 1
- 146 points; Ki-67 21% to 55%
- 15Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection
- 16Participants must have recovered from effects of surgery as determined by the treating investigator
- 17Participants must be \>= 18 years old
- 18Participants must have Zubrod performance status of 0-2
- 19Participants must have a complete medical history and physical exam within 28 days prior to registration
- 20Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to registration)
- 21Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration)
- 22Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration)
- 23Total 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)
- 24Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional ULN (within 28 days prior to registration)
- 25Serum creatinine =\< 1.5 x institutional ULN (within 28 days prior to registration)
- 26Calculated creatinine clearance \>= 50 ml/min (within 28 days prior to registration)
- 27Participants must be able to swallow pills
- 28Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol
- 29No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years
- 30Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
Exclusion Criteria
- 1Participants must not have unresected or unablated metastatic disease
- 2Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis
- 3Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted
- 4Participants must not have received somatostatin analogs after surgery
- 5Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed
- 6Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
- 7Participants must not have known absorption issues that would limit the ability to absorb study agents
- 8Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration
- 9Participants must not have active or uncontrolled infection
- 10Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator
- 11Participants 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
Locations
448 sites participating in this study
Emory University Hospital Midtown
Atlanta, Georgia 30308
Mohammad Y. Zaidi
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Mohammad Y. Zaidi
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Mohammad Y. Zaidi
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →