| Inclusion Criteria: | 1) Have pathologically-confirmed malignancy that is locally advanced or metastatic solid tumor and is refractory to standard therapy or for which conventional therapy is not reliably effective or no effective therapy is available.
2) Be aged >/= 18 years.
3) Have an ECOG Performance Status of 0, 1 or 2.
4) Have adequate clinical laboratory values (i.e., absolute neutrophil count >/= 1.5x10^9/L, platelets >/= 100 x 10^9/L, plasma creatinine </= 1.5 x upper limit of normal (ULN) for the institution; creatinine clearance (calculated) > 60 mL/min (using the Cockcroft Gault equation); bilirubin </= 1.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) </= 2.5 x ULN; patients with known liver metastases may have up to 5 times ULN for AST and ALT levels).
5) Have the ability to cooperate with treatment and follow-up schedules.
6) A negative pregnancy test and using at least one form of contraception as approved by the Investigator prior to study entry if a female patient of childbearing potential or a male patient with a female partner of childbearing potential.
7) Patients may have measurable disease as defined by RECIST criteria or non-measurable disease.
8) Patients with known brain metastases may be included as long as they have been clinically stable for one month or more, and are not receiving dexamethasone.
9) Have the ability to maintain a central intravenous access (e.g. PICC, Groshong, or Hickman line).
10) Signed informed consent prior to the start of any study specific procedures. |