Cabozantinib works by blocking the growth of new blood vessels that feed a tumor. In addition to blocking the formation of new blood cells in tumors, cabozantinib also blocks pathways that may be responsible for allowing cancers cells to become resistant to other "anti-angiogenic" drugs. Cabozantinib has been studied or is being study in research studies as a possible treatment for various types of cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer, and kidney cancer. In this research study, the investigators wish to learn if cabozantinib is effective in treating patients with pancreatic neuroendocrine and carcinoid tumors.
Subjects will take cabozantinib orally, once per day, in cycles of 28 days. During each cycle subjects will have the following procedures: * Physical examination, including measurement of weight and vital signs * Questions regarding any side effects * Blood sample (about 1 tablespoon) for routine laboratory tests of blood cell counts, blood chemistries, organ function and blood clotting * Blood sample (about 4 tablespoons) for research test to measure biomarkers to assess the response to study drug * Urine sample for routine urine tests to monitor health On Day 15 (beginning of week 3) during the first 3 cycles: * Physical examination, including measurement of weight and vital signs * Questions regarding any side effects * Blood sample (about 1 tablespoon) for routine laboratory tests of blood cell counts, blood chemistries, organ function and blood clotting * Blood sample (about 4 tablespoons) for research test to measure biomarkers to assess the response to study drug Subjects will receive a CT scan or MRI every two cycles (every two months) to evaluate disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
60 mg QD orally in cycles of 28 days
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Objective Response Rate (ORR)
The objective response rate of cabozantinib was evaluated according to RECIST v 1.1 criteria (Response Evaluation Criteria In Solid Tumors v 1.1). Disease was assessed using CT and/or MRI scans. RECIST 1.1 criteria include the following categories of disease response: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% or more decrease in the sum of the longest diameter of target lesions; Stable disease (SD) = less than 30% decrease but no more than 20% increase in sum of the longest diameter of target lesions. Objective response rate consisted of CR + PR.
Time frame: Imaging was performed cycles 2,4,6 every 8 weeks for the first 24 weeks, then every 3rd cycle every 12 weeks until progression or EOT. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Cycle=28 days.
Progression Free Survival (PFS)
Progression-free survival was defined as time in months from initiation of treatment until disease progression by RECIST 1.1 criteria or death from any cause. Progressive disease by RECIST 1.1 criteria is defined as at least a 20% increase in the sum of the longest dimensions of target lesions, taking as reference the smallest sum of longest dimensions recorded since the treatment started; the appearance of one or more new lesions; unequivocal progression of existing non-target lesions.
Time frame: Restaging imaging was performed after cycles 2, 4, and 6 (every 8 weeks for the first 24 weeks), then every 3rd cycle (every 12 weeks) until disease progression or end of study treatment. Median follow-up is 89.1 months. Cycle = 28 days.
Overall Survival (OS)
Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
Time frame: Median follow-up time of 89.1 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.