Protocol: Alliance – A021602
Please Note: Below is a partial list of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038 to discuss full eligibility requirements.
- 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 intermediate-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.
- Locally advanced/unresectable or metastatic disease.
- Histological documentation of neuroendocrine tumor of pancreatic, gastrointestinal (GI), lung, thymus, other, or unknown primary site. GI, lung, thymus, other, 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.
- Patients must have measurable disease. Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 1 cm with CT or MRI (or ≥ 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly nonmeasurable including: leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung.
- Patient must have experienced disease progression on or intolerance leading to treatment discontinuation of at least one FDA-approved line of therapy (except somatostatin analogs). Prior lines of therapy may include: everolimus, sunitinib, or lutetium Lu 177 dotatate in patients with pancreatic NET; everolimus in patients with lung NET; everolimus or lutetium Lu 177 dotatate in patients with gastrointestinal NET.
- 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.
- Prior treatment with somatostatin analogs is allowed, and continuation of treatment with somatostatin analogs while on cabozantinib/placebo is allowed provided that the patient has been on a stable dose for at least two months.
- Prior treatment with cabozantinib is not allowed.
- No “currently active” second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a “currently active” malignancy if they have completed therapy and are free of disease for ≥ 3 years.
- Other planned concurrent investigational agents or other tumor directed therapies (chemotherapy, radiation) are not allowed while on this study.
- Must be at least 18 years of age.
- ECOG Performance Status 0-2.