Clinical Trial Information
Protocol: Alliance – A021602
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department 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, 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.
- Target lesions must have shown evidence of disease progression by RECIST v1.1 criteria 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 per Section 6.1.1.
- 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. See Section 11.0 for additional details.
- 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.
- 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.
- Age ≥ 18 years.
- ECOG Performance Status: 0-2.