Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors

Running, not enrolling · Phase 2

Conditions studied: Metastatic Pancreatic Neuroendocrine Tumor, Unresectable Pancreatic Neuroendocrine Carcinoma

In brief

This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). 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. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors.

Key facts

Study ID: NCT05247905
Run by: Alliance for Clinical Trials in Oncology
People needed: 31
Starts: 2023-02-16
Expected to finish: 2033-10-01
Last updated by the study team: 2025-04-02

Who can join

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

You may qualify if…

Histologic or pathologic documentation: well-differentiated pancreatic neuroendocrine tumor (G1, G2, or well-differentiated G3) confirmed by local histology and/or pathology
Functional or nonfunctional tumors are allowed
Stage: locally unresectable or metastatic disease
Tumor Site: neuroendocrine tumor of pancreatic primary site
Radiologic evaluation: tumor must have shown somatostatin receptor (SSTR) positivity on 68Ga-DOTATATE PET or other SSTR-PET scan in the 12 months prior to registration; however, documentation of SSTR positivity in the 6 months prior to registration is preferred. SSTR positivity is defined as uptake greater than background liver in all measurable lesions
Patients are eligible if they meet one of the following criteria:
Previously untreated patients with grade 2 or 3 disease AND with symptoms of either disease bulk causing pain, anorexia, early satiety, large effusions/ascites, abdominal pain, abdominal fullness due to hepatomegaly, dyspnea) OR incompletely controlled symptoms of hormone excess despite somatostatin analogue (SSA) and supportive care (including but not limited to: diarrhea, hypercalcemia, hypoglycemia, hyperglycemia, flushing, Cushing's syndrome). Patient may have been started on SSA for up to 2 months for attempted symptom control without disease progression prior to registration
Patients previously treated with SSA only and with disease progression by RECIST in prior 12 months
Patients previously treated with SSA and one or more prior systemic therapy must have received prior anti-vascular endothelial growth factor (VEGF) pathway therapy inhibitor OR have contraindication to anti-VEGF therapy (including but not limited to: uncontrolled hypertension [systolic blood pressure [SBP] > 150 and/or diastolic blood pressure [DBP] > 90 despite medical management], stage IIB or greater heart disease, angina pectoris, prior arterial [ATE] and venous thromboembolic [VTE] events in the past 6 months, gastrointestinal [GI] bleed in the last 6 months) and disease progression by RECIST in prior 12 months
Patients previously treated with more than 2 lines of therapy, not including anti VEGF therapy, but with NET related symptoms as outlined in first bullet (pain, anorexia, early satiety, large effusions/ascites, abdominal pain, abdominal fullness due to hepatomegaly, anorexia, early satiety, dyspnea) OR incompletely controlled symptoms of hormone excess despite somatostatin analogue (SSA) and supportive care (including but not limited to: diarrhea, hypercalcemia, hypoglycemia, hyperglycemia, flushing, Cushing's syndrome).
Any patient with disease progression by RECIST criteria in < 4 months
Patients must have measurable disease per RECIST v1.1 by computer tomography (CT) scan or magnetic imaging (MRI). Any lesions which have undergone percutaneous therapies or radiotherapy after starting protocol therapy should not be considered measurable unless the lesion has clearly progressed since the procedure.
Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as >= 1 cm with CT or MRI (or shortest diameter >= 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non- measurable including: leptomeningeal disease, bone metastases, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung.
Prior treatment with tyrosine kinase inhibitors (TKIs) such as mammalian target of rapamycin (mTOR) inhibitors (e.g. everolimus, temsirolimus, etc.) or VEGF pathway inhibitors (e.g. sunitinib, pazopanib, cabozantinib, bevacizumab, etc.) are allowed
Prior treatment with hepatic intra-arterial embolic therapies is allowed if there is recovery from all toxicities, measurable lesions do not include embolized liver unless there has been clear subsequent progression, all measurable lesions are somatostatin receptor avid, and treatment completed at least 2 months prior to registration
Prior treatment with cryoablation or thermal/radiofrequency ablation of metastases is allowed if there is recovery from all toxicities, measurable lesions do not include treated metastases, and treatment completed at least 2 months prior to registration
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Absolute neutrophil count (ANC) >= 1,500/mm\^3
Platelet count >= 100,000/mm\^3
Hemoglobin >= 9.0 g/dL
Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min (calculated by the Cockcroft-Gault equation)
Total bilirubin =< 1.5 x ULN (in patients with liver metastases or known Gilbert's syndrome, total bilirubin must be =< 3.0 x ULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x ULN
Albumin >= 3.0 g/dL

You may not qualify if…

Patients with poorly differentiated neuroendocrine carcinoma (large cell histology or small cell histology) are not eligible
No prior temozolomide, dacarbazine, capecitabine, 5-FU, or any PRRT for treatment of the pNET
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects
Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required
No known brain metastases unless adequately treated, demonstrated to be stable, and off all treatment (including steroids) for at least 2 months prior to registration
No uncontrolled congestive heart failure (New York Heart Association [NYHA] II, III, IV).
No significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may pose a risk to patient safety
No "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy or are on adjuvant hormonal therapy and are free of disease for >= 3 years
No known medical condition causing an inability to swallow and no known impairment of gastrointestinal function that may significantly alter the absorption of an oral agent

Where it is running

Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States
Tower Cancer Research Foundation — Beverly Hills, California, United States
Epic Care-Dublin — Dublin, California, United States
Bay Area Breast Surgeons Inc — Emeryville, California, United States
Epic Care Partners in Cancer Care — Emeryville, California, United States
Cedars Sinai Medical Center — Los Angeles, California, United States
Contra Costa Regional Medical Center — Martinez, California, United States
Bay Area Tumor Institute — Oakland, California, United States
Torrance Memorial Physician Network - Cancer Care — Torrance, California, United States
Epic Care Cyberknife Center — Walnut Creek, California, United States
BASS Medical Group - Lennon — Walnut Creek, California, United States
Rocky Mountain Cancer Centers-Aurora — Aurora, Colorado, United States
Boulder Community Foothills Hospital — Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial — Centennial, Colorado, United States
The Women's Imaging Center — Denver, Colorado, United States
Colorado Blood Cancer Institute — Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown — Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose — Denver, Colorado, United States
Mountain Blue Cancer Care Center - Swedish — Englewood, Colorado, United States
Rocky Mountain Cancer Centers - Swedish — Englewood, Colorado, United States
The Melanoma and Skin Cancer Institute — Englewood, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood — Lakewood, Colorado, United States
Fairbanks Memorial Hospital — Fairbanks, Alaska, United States

Full record on ClinicalTrials.gov

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