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

Inclusion Criteria:

* Written Informed Consent.
* Males or females.
* 18-75 years.
* Histologically or cytologically confirmed non-estrogen dependent advanced solid malignancy who has failed standard therapies and/or for which no curative therapeutic option exists (phase I) or ;
* Histologically or cytologically confirmed NSCLC of stage IIIb or IV (phase IIa) that has failed or is ineligible to standard therapies.
* One or more tumor lesions measurable by RECIST criteria
* Life expectancy of at least 3 months.
* ECOG performance of 2 or less.

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.