Liposome Encapsulated Docetaxel (LE-DT) in Patients With Solid Tumors

Inclusion Criteria

• •To be included in this study, patients must meet the following criteria:
• •Be ≥18 years of age.
• •Have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments.
• •Have an ECOG Performance Status of 0-2.
• •Have recovered from acute toxicities of prior treatment:
• •* 4 weeks must have elapsed since receiving any investigational agent.
• •* 4 weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (≥6 weeks for mitomycin or nitrosoureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted.
• •\>6 months must have elapsed since receiving a high-dose chemotherapy regimen with stem cell support.
• •* 2 weeks must have elapsed since any prior surgery or granulocyte-stimulating growth factor therapy.
• •* 12 months must have elapsed since any prior treatment with docetaxel. 5. Be in adequate condition as evidenced by the following clinical laboratory values:
• •* Absolute neutrophil count (ANC) ≥1,500/mm3.
• •* Platelets ≥100,000/mm3.
• •* Hemoglobin ≥9.0 g/dL.
• •* Albumin ≥3.0 g/dL.
• •* Serum creatinine ≤2.0 mg/dL.
• •* Total bilirubin ≤1.5 x institutional upper limit normal (ULN).
• •* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤2.5 x ULN.
• •6\. Patients (male and female) must be willing to practice an effective method of birth control during the study.
• •7\. Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board (IRB)/Independent Ethics Committee approved written informed consent form prior to treatment.