Phase 1 Pancreatic Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed (through a tissue or cell sample) with pancreatic neuroendocrine tumors (PNETs) that have spread or cannot be surgically removed, of any grade (1, 2, or 3)
• People whose tumors show up on a special type of scan (SSR PET/CT) that confirms the tumors are suitable for the type of treatment being studied, as determined by the relevant specialist team
• People who have either not yet received systemic treatment, or whose disease has worsened during or after one prior systemic treatment (not counting somatostatin analog therapy, which is a separate category); prior or ongoing somatostatin analog therapy is allowed
• People who previously received treatment for this cancer and must have documented evidence that the disease progressed within 12 months of starting the study
• People aged 18 years or older (children are excluded because safety data for this combination in younger patients is not yet available)
• People who are reasonably functional in daily life, meeting a standard medical performance measure (ECOG score of 2 or lower, or Karnofsky score of 60% or higher)
• People whose blood test results fall within the required ranges, including: sufficient neutrophils (a type of white blood cell), platelets, hemoglobin, and overall white blood cell count; acceptable liver function (bilirubin, AST, and ALT levels); adequate kidney function (creatinine clearance or GFR above set thresholds); calcium levels within the normal range; and a normal blood clotting measure (INR)
• People with a known history of heart disease, or who have been treated with heart-affecting medications, must have heart function assessed and be classified at a level of 2B or better on a standard heart function scale, with a heart pumping strength (ejection fraction) of 50% or more; people with no known heart history do not need this test at screening
• People with blood pressure no higher than 140/90 mmHg at the time of enrollment; blood pressure medication may be started or adjusted beforehand, as long as the average reading across three measurements is below this level
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months
• People with chronic hepatitis B infection whose viral load is undetectable while on appropriate treatment
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load
• People who previously had brain metastases that were treated, provided that follow-up brain imaging (taken at least 4 weeks after completing that treatment) shows no sign of growth or new disease, and the person has been off steroid medication for at least 1 month and is stable
• People who have had or currently have another cancer, provided the trial site team determines (after consultation with the study chair) that it will not interfere with the safety or results of this study
• People of childbearing potential (women and men) who agree to use reliable contraception throughout the study and for 4 months after completing treatment; women of childbearing potential must have a negative pregnancy test before starting treatment

Who may not be able to join:

• People who have not yet recovered from significant side effects caused by previous cancer treatment (side effects still rated above grade 1, except for hair loss)
• People currently taking part in another clinical trial involving an investigational treatment
• People with a history of serious allergic reactions to medications that are chemically similar to sunitinib malate or lutetium Lu 177 dotatate
• People who need therapeutic doses of warfarin or similar blood-thinning medications (low-dose warfarin up to 2 mg daily for clot prevention is permitted; low molecular weight heparin and other non-warfarin blood thinners may be used with caution)
• People who are unable to swallow tablets or absorb oral medication properly, due to conditions such as gastrointestinal disease, past bowel surgery affecting absorption, the need for intravenous nutrition, or active stomach ulcers
• People with any of the following conditions: a serious or non-healing wound, ulcer, or bone fracture; a history of abdominal fistula, bowel perforation, or internal abdominal abscess within the past 28 days; a stroke or mini-stroke (TIA) within the past 12 months; a heart attack, heart rhythm problems, angina, heart failure symptoms, or heart bypass/stent procedure within the past 12 months; a blood clot in the lungs within the past 12 months; or severe heart failure classified as Class III or IV on the standard heart function scale
• People who are currently taking strong medications that significantly affect how sunitinib is processed by the body (specifically, strong CYP3A4 inhibitors within the past 7 days, or strong CYP3A4 inducers within the past 12 days) (confirm with trial site)
• People with a pre-existing thyroid condition whose thyroid levels cannot be kept within the normal range even with medication
• People with serious ongoing illnesses that are not well controlled
• People who are pregnant, as both study treatments carry risks to a developing baby; people who are breastfeeding are also excluded, and breastfeeding must not resume until at least 2.5 months after the final dose of lutetium Lu 177 dotatate
• People who have previously been treated with sunitinib malate, lutetium Lu 177 dotatate, or other radiopharmaceutical treatments (such as MIBG, yttrium-90, or radioactive iodine), due to the risk of serious and potentially irreversible blood-related side effects

Important: Always verify eligibility with the trial site directly before applying.