Ziv-Aflibercept for Advanced Progressive Carcinoid Tumors
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of
an investigational drug to learn whether the drug works in treating a specific cancer.
"Investigational" means that the drug, Ziv-aflibercept, is being studied. It also means that
the FDA has not yet approved Ziv-aflibercept for use in patients with your type of cancer.
Every person has molecules in their bloodstream called vascular endothelial growth factors
(VEGFs). These molecules help grow and sustain new blood vessels needed by the human body.
Cancer tumors hijack this mechanism because they need new blod vessels and oxygen to grow.
Ziv-aflibercept is an antibody. Antibodies are proteins that are produced naturally in our
bodies and help to recognize foreign substances in our body. Ziv-aflibercept is a "targeted
therapy" called a "VEGF Trap", that "traps" (binds) these VEGFs and prevents the cancer from
using them to grow.
Though Ziv-aflibercept has not yet been FDA approved for the treatment of carcinoid tumors,
it has recently been approved for patients with treatment-resistant colorectal cancer.
In this research study, we will use Ziv-aflibercept in combination with standard octreotide
therapy to see if it slows the growth or spread of your carcinoid tumor. Standard octreotide
(sandostatin) therapy is currently approved for treating symptoms of carcinoid tumors, such
as those caused by carcinoid syndrome. Carcinoid syndrome is caused by hormones and other
substances released by carcinoid tumors into the bloodstream. One of these secreted
substances is serotonin, one of the body's natural chemical messengers. When excess serotonin
secreted by the carcinoid tumors reaches the body's tissues, it is thought to cause diarrhea
and redness (flushing) of the face, chest or back. Excess serotonin may also cause changes in
the structure of the heart valves, which can impair the heart's function. Octreotide works by
binding to receptors found on carcinoid tumors and prevents the release of hormones from the
tumor.