CompletedPhase 2

Ziv-Aflibercept for Advanced Progressive Carcinoid Tumors

United States19 participantsStarted 2013-02-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed well differentiated or moderately differentiated neuroendocrine tumor from either a primary or metastatic site * Must have disease that is not amenable to curative resection * Must have evidence of disease progression within 12 months prior to study entry * Must have measurable disease (RECIST 1.1) * Prior chemoembolization of local ablative therapies are allowed, provided there is measurable disease outside of the area treated, or documented evidence of progression at the site of prior treatment * No limit to number of prior treatments. Prior bevacizumab allowed unless discontinued due to unacceptable toxicity. Prior TKI targeting VEGF receptors allowed * Treatment with a somatostatin analog required for all subjects * Subjects with history of hypertension must be adequately controlled * Therapeutic anticoagulation is allowed. Must be on a stable dose of anticoagulant medication * Must agree to use adequate contraception prior to study entry, for the duration of study participation and for 3 months after last administration of study drug Exclusion Criteria: * Prior treatment including chemoembolization within 4 weeks of study entry * Major surgery within 4 weeks of study entry or minor surgery within 2 weeks of study entry * Pregnant or breastfeeding * Poorly differentiated carcinoma, high grade neuroendocrine tumor or small cell carcinoma * Prior treatment with Ziv-aflibercept * Pancreatic neuroendocrine tumor (islet cell ca…

What they're measuring

Progression Free Survival

Timeframe: 2 years

Trial details

NCT IDNCT01782443

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03

Results submitted2022-07-22