[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iii-pancreatic-neuroendocrine-tumor-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iii-pancreatic-neuroendocrine-tumor-ajcc-v8":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100492052","phase-1-testing-the-addition-of-sunitinib-malate-to-lutetium-lu-177-dotatate-lutathera-in-pancreatic-neuroendocrine-tumors-100492052",false,"NCT05687123","Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors","A Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine Tumors","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed metastatic or unresectable well- or moderately-differentiated pancreatic neuroendocrine tumors (PNETs) of all grades (Grade 1, grade 2 and grade 3)\n* Patients with measurable disease per RECIST 1.1 appropriate for lutetium Lu 177 dotatate treatment, as determined by positive screening with SSR PET\u002FCT and appropriate theranostics consultation (nuclear medicine or radiation oncology consultation)\n* Patients may be treatment naïve or have disease progression on or intolerance of up to one line of systemic therapy other than somatostatin analog therapy (somatostatin analog therapy is not considered a line of systemic therapy). Systemic therapy is considered therapy for unresectable or metastatic disease. Any prior adjuvant therapy with curative intent will not be considered a line unless relapse occurs within 6 months. Prior and\u002For concurrent use of somatostatin analogs are allowed\n* Patients who have have received a prior line of therapy must have documented disease progression per RECIST 1.1 within 12 months of initiation of the study protocol\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of sunitinib malate in combination with lutetium Lu 177 dotatate in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1,000\u002FmcL\n* Platelets \\>= 75,000\u002FmcL\n* Total bilirubin =\\\u003C 1.5 institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 × institutional ULN\n* Creatinine clearance \\> 50 ml\u002Fmin OR Glomerular filtration rate (GFR) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2\n* Hemoglobin \\> 8.0 g\u002FdL\n* White blood cell count \\> 2000\u002FmL\n* Serum calcium =\\\u003C 12.0 mg\u002FdL\n* International normalized ratio (INR) =\\\u003C 1.5\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better and have left ventricular ejection fraction of 50% or more. (Patients with no known history and no current symptoms of cardiac disease do not require left ventricular ejection fraction \\[LVEF\\] evaluation at screening)\n* Patients must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility. Initiation or adjustment of BP medication is permitted prior to study entry, provided that the average of three BP readings at a visit prior to enrollment is less than 140\u002F90 mmHg\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression, as determined by a repeat imaging study at least 4 weeks following the completion of treatment. Patients with treated brain metastases must also be off steroids for at least 1 month and stable\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial after consultation with the study chair\n* The effects of lutetium Lu 177 dotatate and sunitinib malate on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radionucleotides and anti-angiogenic agents are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. All women of childbearing potential must have a negative pregnancy test prior to receiving sunitinib malate. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of lutetium Lu 177 dotatate and sunitinib malate administration\n\nExclusion Criteria:\n\n* Patients who have not recovered from acute clinically significant adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate or lutetium Lu 177 dotatate\n* Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis. Note: Low molecular weight heparin is permitted provided the patient's INR is =\\\u003C 1.5 and is the preferred anticoagulant in this trial. Other non-coumarin-derivative anticoagulants including direct oral anticoagulants may be used with caution\n* Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain sunitinib tablets are excluded\n* Patients with any of the following conditions are excluded:\n\n  * Serious or non-healing wound, ulcer, or bone fracture\n  * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment\n  * Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry\n  * History of myocardial infarction, cardiac arrhythmia, stable\u002Funstable angina, symptomatic congestive heart failure, or coronary\u002Fperipheral artery bypass graft or stenting within 12 months prior to study entry\n  * History of pulmonary embolism within the past 12 months\n  * Class III or IV heart failure as defined by the New York Heart Association Class (NYHA) functional classification system\n* Patients receiving any medications or substances that are strong CYP3A4 inhibitors within 7 days before dosing, or strong CYP3A4 inducers within 12 days before dosing, are ineligible as sunitinib is a major substrate of CYP3A4. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible\n* Patients with uncontrolled intercurrent illness\n* Pregnant women are excluded from this study because sunitinib malate is an anti-angiogenic agent and lutetium Lu 177 dotatate is a peptide receptor radionuclide therapy with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib malate and lutetium Lu 177 dotatate, breastfeeding should be discontinued if the mother is treated with sunitinib malate and lutetium Lu 177 dotatate. Breastfeeding should be discontinued for 2.5 months following the last lutetium Lu 177 dotatate treatment. These potential risks may also apply to other agents used in this study\n* Patients who have had prior treatment with sunitinib malate or lutetium Lu 177 dotatate therapy or other radiopharmaceuticals (including, but not limited to, metaiodobenzylguanidine \\[MIBG\\], yttrium-90 \\[Y-90\\], radioactive iodide \\[RAI\\]), as MIBG and RAI could potentially increase risk of myelodysplastic syndrome or irreversible hematologic toxicities","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.",[26,27,28,29,30],"Metastatic Pancreatic Neuroendocrine Tumor","Pancreatic Neoplasm","Stage III Pancreatic Neuroendocrine Tumor AJCC v8","Stage IV Pancreatic Neuroendocrine Tumor AJCC v8","Unresectable Pancreatic Neuroendocrine Tumor","RECRUITING","2026-05-12",{"date":34,"type":35},"2026-05-13","ACTUAL",{"date":37,"type":35},"2024-08-14",{"date":39,"type":20},"2026-12-14",{"name":41,"class":42},"National Cancer Institute (NCI)","NIH",10,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100442359","phase-2-testing-the-use-of-chemotherapy-after-surgery-for-high-risk-pancreatic-neuroendocrine-tumors-100442359","NCT05040360","Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors","Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors","Inclusion Criteria:\n\n* 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\n* Resection must have been an R0 or R1 per treating investigator's assessment and\u002For pathology report\n* 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 =\\\u003C 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and\u002For 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\n* Participants with localized resected pNETS must have a Zaidi score of \\>= 3 derived by the following factors and points:\n\n  * 1 point; symptomatic tumor defined as one of the following:\n\n    * Gastrointestinal bleed\n    * Jaundice\n    * Gastrointestinal obstruction\n    * Pain from primary tumor prior to surgical resection\n    * Pancreatitis\n  * 2 points; primary pancreas tumor size \\> 2 cm\n  * 1 point; Ki-67 3% to 20%\n  * 1 point; lymph node positivity = 1\n  * 6 points; Ki-67 21% to 55%\n* Participants may have received resection\u002Fablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection\n* Participants must have recovered from effects of surgery as determined by the treating investigator\n* Participants must be \\>= 18 years old\n* Participants must have Zubrod performance status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Leukocytes \\>= 3 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Absolute neutrophil count \\>= 1.5 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Platelets \\>= 100 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Total bilirubin =\\\u003C institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x institutional ULN (within 28 days prior to registration)\n* Serum creatinine =\\\u003C 1.5 x institutional ULN (within 28 days prior to registration)\n* Calculated creatinine clearance \\>= 50 ml\u002Fmin (within 28 days prior to registration)\n* Participants must be able to swallow pills\n* Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol\n* No 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\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n\nExclusion Criteria:\n\n* Participants must not have unresected or unablated metastatic disease\n* Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis\n* Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted\n* Participants must not have received somatostatin analogs after surgery\n* Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed\n* Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine\n* Participants must not have known absorption issues that would limit the ability to absorb study agents\n* Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration\n* Participants must not have active or uncontrolled infection\n* Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator\n* 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\u002Focclusion, and vasectomy with testing showing no sperm in the semen",{"count":52,"type":20},141,[54],"PHASE2","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.",[57,58,59,60,28],"Metastatic Malignant Neoplasm in the Liver","Pancreatic Neuroendocrine Tumor","Stage I Pancreatic Neuroendocrine Tumor AJCC v8","Stage II Pancreatic Neuroendocrine Tumor AJCC v8","2025-12-10",{"date":63,"type":35},"2025-12-15",{"date":65,"type":35},"2022-05-05",{"date":67,"type":20},"2027-03-31",{"name":69,"class":70},"SWOG Cancer Research Network","NETWORK",448]