TAS-102 in Extrapulmonary Neuroendocrine Carcinoma

Exclusion Criteria

• •Women who are pregnant or breastfeeding.
• •Evidence of low-grade or well-differentiated features as determined by the investigator.
• •Functional neuroendocrine tumors are excluded.
• •Known pulmonary primary or small cell lung cancer will be excluded.
• •Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias within the last six months.
• •Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever (temp \> 38°C).
• •Other severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as: a) Severe impaired lung functions as defined by spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air, b) Uncontrolled diabetes,c) Liver disease such as cirrhosis or severe hepatic impairment, d) Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the integrity of the study.
• •Taking other investigational or anti-cancer treatments while participating in this study. Concurrent radiotherapy is allowed provided to non-target lesions. If target lesions have received radiation therapy, progression must have been demonstrated prior to enrollment.
• •Prior or concurrent malignancy, except for the following: a) Adequately treated basal cell or squamous cell skin cancer; b) Cervical carcinoma in situ; c) Adequately treated Stage I or II cancer from which the subject is currently in complete remission; d) Or any other cancer from which the subject has been disease-free for 3 years.