Multicenter Phase 2 study of 212Pb-DOTAMTATE enrolling adult subjects with positive somatostatin positive neuroendocrine tumors with either no prior history of peptide receptor radionuclide therapy (PRRT naive) or prior history of peptide receptor radionuclide therapy (Previous PRRT)
In this open-label, multicenter, single-arm Phase 2 study, adult subjects with histologically confirmed NETs and positive somatostatin analog imaging, with either no prior PRRT (PRRT naive) or prior history of peptide receptor radionuclide therapy (previous PRRT) will be enrolled to receive 212Pb-DOTAMTATE 67.6 μCi/kg dose per cycle
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
212Pb-DOTAMTATE is a radiolabeled derivative of octreotide targeting somatostatin positive neuroendocrine tumors
Rocky Mountain Cancer Center
Denver, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Louisiana State University (LSU) Health Sciences Center - New Orleans
Metairie, Louisiana, United States
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, United States
Measurement of the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
The morphological imaging (CT/MRI) will be done before therapy and selected time points before therapy cycle to determine changes in the size of target lesions.
Time frame: 24 months after last dose administration
Number of patients with treatment-related adverse events as assessed by CTCAE v.4.0
To assess the safety and tolerability of 212Pb-DOTAMTATE
Time frame: 24 months after last dose administration
Measurement of the Median Progression free survival (mPFS)
PFS will be defined as the number of days from the first dose of 212Pb-DOTAMTATE to documented tumor progression per RECIST 1.1 criteria or death due to any cause.
Time frame: 24 months after last dose administration
Measurement of Overall Survival (OS)
OS will be defined as the number of days from the first dose of 212Pb-DOTAMTATE to the date of death due to any cause or the date of last contact (censored observations) at the data cut-off date.
Time frame: 24 months after last dose administration
Measurement of Time to Tumor Progression (TTP)
This measurement will determine the time from start of treatment with 212Pb- DOTAMTATE until disease progression.
Time frame: 24 months after last dose administration
To evaluate health-related quality of life (HRQL) using ECOG performance status
Changes in quality of life will be assessed relative to baseline. Eastern Cooperative Oncology Group (ECOG) is designed to measure how cancer affects subject's daily life and is assessed using 0-5 scale.
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Time frame: 24 months after last dose administration
To evaluate health-related quality of life (HRQL) using HRQL questionnaire EORTC QLQ-C30
Changes in quality of life will be assessed relative to baseline. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a self-assessed questionnaire that consists of 30 questions designed to measure varying types of functioning, symptoms and overall health/quality of life. It is assessed using either a 4-point scale or 7-point scale, depending on the question.
Time frame: 24 months after last dose administration
To evaluate health-related quality of life (HRQL) using HRQL questionnaire EORTC QLQ-G.I.NET21
Changes in quality of life will be assessed relative to baseline. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-G.I.NET21 is a self-assessed questionnaire that consists of 51 questions designed to assess symptoms or problems. It is assessed using a 4-point scale.
Time frame: 24 months after last dose administration