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

Protocol: 
AAAR9087
Phase: 
II

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

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. 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. The use of temozolomide and
capecitabine could shrink your cancer but it could also cause side effects.
For patients who receive the usual treatment for this cancer, it is usually
about 6 months before the usual treatment stops working and a different
treatment is needed. To be better, the study drugs should increase how long
you are able to live with your cancer before you need to switch to different
treatment, by 4 months or more compared to the usual approach. There will be
about 126 people taking part in this study.

Are you Eligible? (Inclusion Criteria)

1) Do you have locally advanced and unresectable or metastatic
gastroenteropancreatic neuroendocrine carcinoma?

2) Have you not had any prior systemic treatment for this malignancy?

3) Are you 18 years of age or greater?

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States