A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer

Exclusion Criteria

• •1. Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
• •2. Known brain metastases
• •3. Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)
• •4. Active infection requiring antibiotic therapy
• •5. History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
• •6. Grade 2 or greater motor or sensory neuropathy
• •7. Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
• •8. Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.
• •9. Known or suspected hypersensitivity to azacitidine or mannitol
• •10. Pregnant or breast feeding
• •11. Patients with advanced malignant hepatic tumors
• •12. Malignancy other than breast carcinoma (phase II)
• •13. Known HIV infection or chronic hepatitis B or C