The purpose of this study is to determine if carfilzomib is safe and effective in the treatment of patients with advanced neuroendocrine tumors.
Neuroendocrine malignancies such as pancreatic neuroendocrine tumors (PNETs) and gastrointestinal (GI) carcinoids, are generally rare but their incidences are increasing. In vitro and in vivo studies have shown that proteasome inhibitors have activity against a variety of tumor types. Carfilzomib (Kyprolis®) is an irreversible proteasome inhibitor with a favorable safety profile that has been studied in a variety of hematologic and solid tumors. Carfilzomib received accelerated approval from the U.S. FDA in 2012, based on a favorable response rate, for the treatment of patients with multiple myeloma who received at least two prior therapies, and demonstrated disease progression within 60 days of completing the last therapy. In this multi-center study, the investigators propose to evaluate carfilzomib for the treatment of patients with advanced neuroendocrine cancers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Rocky Mountain Cancer Center
Denver, Colorado, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Overall Response Rate (ORR)
Percentage of participants with confirmed complete response (CR) or partial response (PR) (i.e. 2 CRs or PRs at least 4 weeks apart) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) CR=disappearance of all target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years
Disease Control Rate (DCR)
Percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) (≥ 6 cycles) according to RECIST v1.1 criteria. Complete Response is defined per RECIST as the disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease is defined per RECIST as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since the treatment started.
Time frame: every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years
Progression Free Survival (PFS)
Measured from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on the study. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions. Patients who did not have disease progression or death documented were censored on the date of the last visit with adequate assessment.
Time frame: up to 4 years
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
The number of treatment-emergent adverse events will be graded utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
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Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Ingalls Cancer Research Center
Harvey, Illinois, United States
Research Medical Center
Kansas City, Missouri, United States
Oncology Hematology Care, INC.
Cincinnati, Ohio, United States
Spartanburg Regional Medical Center/Gibbs Cancer Center
Spartanburg, South Carolina, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Time frame: From the day of the first dose to 30 days after the last dose of study medication, up to 4 years