MTD Determination, Safety and Efficacy of the Decitabine-Genistein Drug Combination in Advanced Solid Tumors and Non-Small Cell Lung Cancer

Exclusion Criteria

• •Prior decitabine or genistein therapy.
• •Received cytotoxic agent, hormonal therapy, radiation therapy, or other targeted cancer therapies or investigational agent within 4 weeks prior to study entry.
• •Patients with confirmed estrogen receptor-positive cancers, or patients with a primary breast or endometrial cancer for which phenotyping analysis has not been performed.
• •Presence of uncontrolled brain metastases or leptomeningeal disease.
• •Uncontrolled cardiovascular disorders, including symptomatic heart failure, unstable angina and cardiac arrhythmias.
• •Inadequate baseline organ function as shown by following laboratory values :
• •* Hemoglobin \< 90 g/L
• •* Absolute neutrophil count \< 1,500 /microliter
• •* Platelet count \< 100,000 /microliter
• •* Total bilirubin \> 1.5 ULN
• •* AST and ALT \> 2.5 ULN
• •* Creatinine clearance \< 60 ml/min
• •To be dependent of oxygen treatment.
• •Active infections requiring antibiotics.
• •Pregnancy or breastfeeding. All women of child-bearing potential must have a negative pregnancy test prior to first receiving protocol therapy.
• •Known allergic reactions to soy derivatives or deoxycytidine derivatives.
• •Active alcohol or drug abuse.
• •Any co-morbid condition that in the judgment of the investigator renders the subject at high risk of treatment complication or reduces the probability of assessing clinical effect.
• •Other malignancies diagnosed within the last 5 years with the exception of Basal Cell Carcinoma of the skin.
• •Gastrointestinal disorders or abnormalities that may interfere with the absorption of genistein.
• •Patients unable to comply with the study protocol and follow-up schedule for any psychological, familial, sociological or geographical reason.