Safety Study of a Liposomal Docetaxel Formulation in Patients With Solid Tumors Who Have Failed Previous Therapies

Inclusion Criteria:

* Understand and sign a written IRB-approved informed consent form.
* Have a histologically confirmed solid tumor.
* Have progressive disease following standard/approved chemotherapy or have no appropriate alternative therapy available.
* Have one or more tumors measurable or evaluable as outlined by modified RECIST or evaluable by CT or MRI scan.
* Have an ECOG performance status of ≤ 2.
* Have a life expectancy of at least 3 months.
* Be ≥ 18 years old.
* Have a negative pregnancy test (if female of childbearing potential)
* Demonstrate acceptable hepatic function:
* Bilirubin ≤ upper limit of normal (ULN)
* AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
* Demonstrate acceptable renal function:
* Serum creatinine ≤ 1.5 x ULN, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (Calculated according to the Cockroft and Gault formula)
* Demonstrate acceptable hematologic status:
* Absolute neutrophil count ≥ 1500/mm3
* Platelet count ≥ 100,000/mm3 (measured within 72 hours prior to initial dose)
* Hemoglobin ≥ 9 g/dL
* Demonstrate acceptable coagulation status:
* PT or INR within 1.5x ULN
* PTT within 1.5x ULN
* Have recovered from prior treatments (eg, surgery, radiation, chemotherapy, investigational therapies) sufficiently prior to Day 1 so that, in the opinion of the Investigator and/or Medical Monitor, the protocol objectives would not be compromised.
* Agree to use an effective contraceptive method (hormonal or barrier method; or abstinence) for the duration of the study and for 30 days after the last dose (for men and women of child-producing potential).

Exclusion Criteria:

* Have New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG).
* Have a seizure disorder requiring anticonvulsant therapy.
* Have active CNS metastasis. Patients with a history of CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on stable dose of steroids for ≥ 1 week prior to enrollment.
* Have severe, chronic obstructive pulmonary disease with hypoxemia.
* Have active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
* Are pregnant or nursing.
* Have undergone radiation therapy, surgery, chemotherapy, or investigational therapy within 28 days prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
* Are unwilling or unable to comply with procedures required in this protocol.
* Have a known history of infection with HIV, hepatitis B, or hepatitis C.
* Have a serious nonmalignant disease that, in the opinion of the Investigator and/or the Medical Monitor, could compromise protocol objectives.
* Are currently receiving any other investigational agent.
* Have exhibited allergic reactions to docetaxel, or a similar structural compound, biological agent, or formulation.