STA-4783 and Paclitaxel for Treatment of Solid Tumors

Inclusion Criteria

• •Male and female patients greater than or equal to 18 years of age with histologically confirmed malignancy that is metastatic or unresectable and for which no standard therapy exists.
• •Patients must not have received prior chemotherapy or radiation for greater than or equal to 4 weeks before study enrollment.
• •Patients may be entered if they have received prior radiation therapy involving less than or equal to 30% of the bone marrow. Any prior radiation therapy must have been administered greater than or equal to 4 weeks before study enrollment and the patient must be recovered from the acute toxic effects of the treatment prior to study entry.
• •Patients may be enrolled with a history of treated brain metastases that are clinically stable for greater than or equal to 4 weeks prior to enrollment.
• •ECOG Performance Status of less than or equal to 2.
• •Life expectancy of greater than 12 weeks.
• •No peripheral neuropathy \> grade 1 on NCI CTC version 2 scale, no history of stroke or other significant neurological limitations as determined by the investigator.
• •Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below.
• •Absolute neutrophil count greater than or equal to 1,500/ul
• •Platelets greater than or equal to 100,000 cells/ul
• •Total bilirubin must be within normal limits
• •AST(SGOT) less than or equal to 2.5 times the upper limit of normal
• •Serum creatinine \< 1.5 mg/dl or a measured creatine clearance greater than or equal to 50 mL/min
• •Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by investigator.
• •The effects of STA-4783 on the developing human fetus are unknown, however taxanes are known to be teratogenic. Therefore, women of childbearing potential (defined as women less than or equal to 50 years of age or history of amenorrhea for \< 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• •Ability to understand and the willingness to sign a written informed consent document.