| Inclusion Criteria: | 1) Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard tehrapy, or has no standard therapy that improves survival by at least three months.
2) All patients must have an estimated life expectancy of at least 12 weeks.
3) Patients must have measurable or evaluable disease
4) Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study. Six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosurea). Five half-lives will be required for biologic/targeted therapies with short (<24 hour) half-lives and pharmacodynamic effects. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
5) ECOG performance status </= 2 (Karnofsky >/= 60%).
6) Patients must have organ and marrow function defined as: absolute neutrophil count >/= 1,500/mL; platelets >/=100,000/mL; creatinine </= 3 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 5 X ULN. In patients with significant liver disease and chronically elevated liver transaminases, ALT may be elevated as high as 8 X ULN.
7) Cardiac ejection fraction >/= 50% without evidence of CHF
8) Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.
9) Ability to understand and the willingness to sign a written informed consent document.
10) Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies except hormonal maintenance treatment for prostate cancer. |