Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors (NCT01466036) | Clinical Trial Compass
CompletedPhase 2
Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
United States61 participantsStarted 2012-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Locally unresectable or metastatic, histologically-confirmed, carcinoid or pancreatic neuroendocrine tumor. Tumors must be considered well- or moderately-differentiated. Patients with poorly differentiated neuroendocrine carcinoma or cell carcinoma are excluded from the study.
* A tumor sample is required for enrollment (except for patients diagnosed \> 7 years ago).
* Must have measurable disease by RECIST criteria
* Must have evidence of progressive disease within 12 months of study entry
* Prior or concurrent therapy with somatostatin analogs is permitted. If on somatostatin/octreotide, must be on a stable dose for at least two months.
* Age ≥ 18 years
* No major surgery or radiation in the prior 4 weeks prior to enrollment
* No prior therapy with cabozantinib
* ECOG Performance status ≤ 1
* Participants must have adequate organ and marrow function as defined below:
* Absolute neutrophil count \> 1,500/mcL
* Platelets \> 100,000/mcL
* Total bilirubin \</= 1.5X normal institutional limits
* AST (SGOT) and ALT (SGPT) \</=2.5x normal institutional limits, or \< 5x if liver metastases are present
* Creatinine \</= 1.5x normal institutional limits or creatinine clearance \> 50mL/min
* Urine Protein:Creatinine ratio of \<1
* Lipase \< 1.5X upper limit of normal
* Serum Albumin ≥ 2.8 g/dl
* Sexually active subjects must agree to use medically accepted methods of birth control during the course of the study and for 3 months following discont…
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 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.