EA2142 Randomized Phase II Study of Platinum and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas
Ana De jesus-acosta
Johns Hopkins Kimmel Cancer Center in Baltimore
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.
Generally healthy adults with neuroendocrine cancer may be eligible.
This study has two study groups, which are referred to as Group 1 and Group 2. Group 1 will receive the study drugs temozolomide and capecitabine. Group 2 will receive the usual care treatment of platinum therapy and etoposide.If you are in Group 1, you will be taking your treatment orally. You will use a pill diary, which you must bring to each clinic visit. 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. This 28 day period is called a cycle.If you are in Group 2, you 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. This 21 day period is called a cycle.A computer will by chance assign you to treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other. You will have an equal, or 50/50, chance of being in either group.You will receive the assigned chemotherapy treatment for as long as it seems to be working for you or until the side effects become too severe for you. After you finish your chemotherapy, your doctor will continue to watch you for side effects 30 days following your last treatment. Your doctor will follow your condition for the study for up to 5 years from when you first started the study.
01/17/2020 05:03 AM