A Randomized, Double-Blind Phase III Study of Cabozantinib Vs. Placebo in Patients with Advanced Neuroendocrine Tumors After Progression on Everolimus

October 17, 2019

Research & Trial Information

SCHEMA A021602

Protocol#: Alliance – A021602

Cancer Type: Neuroendocrine

Patient Eligibility:

  1. Well- or moderately-differentiated neuroendocrine tumors of pancreatic and non-pancreatic (i.e. carcinoid) origin by local pathology.The pathology report must state ONE of the following: 1) well- or moderatelydifferentiated neuroendocrine tumor, 2) low- or  ntermediate-grade neuroendocrine tumor, or 3) carcinoid tumor or atypical carcinoid tumor.

    Documentation of histology from a primary or metastatic site is allowed.

    Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible.

  2. Locally advanced/unresectable or metastatic disease.
  3. Histological documentation of neuroendocrine tumor of pancreatic, gastrointestinal (GI), lung, or unknown primary site. GI, lung, and unknown primary NETs will enroll in the carcinoid tumor cohort of the study.Functional (associated with a clinical hormone syndrome) or nonfunctional tumors are allowed.
  4. Target lesions must have shown evidence of disease progression in the 12 months prior to registration. The radiologic images, imaging reports, and clinic notes indicating growth of existing lesions, development of new lesions, or treatment changes must be submitted.
  5. Patients must have measurable disease by computer tomography (CT) scan or magnetic resonance imaging (MRI).
  6. Patient must have failed at least one prior systemic therapy that included everolimus. Disease progression or treatment intolerance leading to discontinuation is considered treatment failure.Prior treatment (except somatostatin analogs) with biologic therapy, immunotherapy, chemotherapy, investigational agent for  malignancy, and/or radiation must be completed at least 28 days prior to registration.
  7. Other planned concurrent investigational agents or other tumor directed therapies (chemotherapy, radiation) are not allowed while on this study.
  8. No class III or IV CHF within 6 months of registration. No clinically significant cardiac arrhythmia within 6 months of registration. No unstable angina or MI within 6 months of registration. No thromboembolic events within 6 months of registration (incl. stroke, TIA, DVT, & PE). No uncontrolled hypertension within 14 days of registration.
  9. Age ≥ 18 years.
  10. ECOG Performance Status: 0-2.

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Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium


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