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Protocol No. EA2142

Principal Investigator Lubner, Sam

Phase II

Age Group Adult

Scope National

Sponsor Type National

Title Randomized Phase II Study of Platinum and Etoposide Versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas

Objective The purpose of this study is to compare the effects, both good and bad, of the study drugs temozolomide and capecitabine to the usual chemotherapy treatment for this disease of cisplatin or carboplatin (referred to as "platinum therapy") and etoposide.

Treatment Usually the first treatment given for this cancer is platinum therapy and etoposide. The chemotherapy drugs temozolomide and capecitabine are also used to treat this disease but usually not until the first treatment, platinum therapy and etoposide, stops working. It is not known if this is the best approach or if the temozolomide and capecitabine should be given first instead.

Description A computer will by chance assign you to treatment groups in the study, either Group I or Group 2.. This is called randomization. Group 1 will receive the study drugs temozolomide and capecitabine. These drugs will be taken orally. If you are in this group, you will take one medicine (the capecitabine) twice a day for 14 days. During the last 5 days of the capecitabine treatment, you will take temozolomide once a day as well. After the 14 days of treatment, you will have 14 days off from treatment before you start any further treatment. Group 2 will receive platinum therapy and etoposide through a vein. You will receive your treatment at a clinic visit once a day for three days in a row, and then you will have 18 days off before you receive any further treatment.

Key Eligibility
  • Patients must have a locally advanced and unresectable or metastatic gastroenteropancreatic neuroendocrine carcinoma that is either known or suspected to be of GI origin
  • Patients must have pathologically/histologically confirmed tumor of non-small cell histology
  • Patients may not have had any prior systemic treatment for this malignancy
  • Patients may not have received any of the protocol agents within 5 years prior to randomization
  • Any prior surgeries must have been completed at least 4 weeks prior to randomization
  • Patients may not be receiving Coumadin while on treatment. Other anticoagulants are allowed
  • Patients with brain metastases (either remote or current) or presence of carcinomatous meningitis are not eligible
  • Patients with symptomatic peripheral vascular disease are not eligible
  • Women must not be pregnant or breast-feeding
  • Patients who are known to have HIV or are on combination antiretroviral therapy are ineligible

Applicable Disease Sites Pancreas

Status Open

Participating Institutions Johnson Creek, UW Cancer Center; UW Hospital and Clinics