Neuroendocrine Carcinoma
Conditions
Brief summary
carboplatin and etoposide, followed by maintenance therapy with weekly paclitaxel in patients with poorly differentiated neuroendocrine carcinomas. We hope to identify a standard treatment for this unusual group of patients who are not usually eligible for clinical trials.
Detailed description
Upon determination of eligibility, patients will be receive: * Paclitaxel + Carboplatin + Etoposide
Interventions
DRUGPaclitaxel
DRUGCarboplatin
DRUGEtoposide
Sponsors
Bristol-Myers Squibb
SCRI Development Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in this study, you must meet the following criteria: * Metastatic poorly differentiated neuroendocrine carcinoma * Unknown primary site * Able to perform activities of daily living with minimal assistance * Measurable or evaluable disease * Adequate bone marrow, liver functions and kidney function * No previous treatment with chemotherapy * Understand the nature of this study and give written informed consent.
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Age \< 18 years * Previous malignancy within five years * Women pregnant or lactating * Recent history of cardiovascular disease * Meningeal metastases Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | — |
| Time to progression | — |
| Overall toxicity | — |
Outcome results
None listed