Phase II Randomized Study of Cisplatin and Etoposide Vs. Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas

April 9, 2020

Clinical Trial Information



Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.


  1. Patients must have a locally advanced and unresectable or metastatic gastroenteropancreatic neuroendocrine carcinoma that is either
    known or suspected to be of GI origin. Primary tumors arising from the lung, gynecologic organs or prostate are not permitted.
  2. Patients must have pathologically/histologically confirmed tumor of non-small cell histology.
  3. Patients must have a Ki-67 proliferative index of 20-100% OR at least 10 mitotic figures per 10 high powered fields.
  4. Patients must have measurable disease/
  5. Patients may not have had any prior systemic therapy (chemotherapy, targeted therapy, PRRT) for this malignancy. Prior somatostatin
    therapy is permitted. Prior palliative radiation is permitted but radiated lesions may not be used for measurement.
  6. Patients may not have received any of the protocol agents within 5 years prior to randomization.
  7. Patients must be at least ≥ 18 years of age.
  8. Patients must have an ECOG performance status of 0-2.
  9. Patients may not be receiving any other investigational agents while on study treatment.
  10. Patients may not be receiving Coumadin while on treatment. Other anticoagulants are allowed.
  11. Patients must have a life expectancy of ≥ 12 weeks as determined clinically by the treating physician.
  12. Patients with brain metastases (either remote or current) or presence of carcinomatous meningitis are not eligible.

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