A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel

Inclusion Criteria

• •Histologically proven advanced solid tumors.
• •2 prior chemotherapy regimens.
• •Age greater than or equal to 18 years.
• •Eastern Cooperative Oncology Group performance status 0-1.
• •Life expectancy greater than 3 months.
• •At least 4 weeks between prior surgery or radiotherapy and enrollment.
• •Adequate organ function as defined by the following criteria (must be obtained within 1 week of the first day of treatment):
• •Absolute neutrophil count ≥ 1500/µL. Hemoglobin ≥ 10.0 g/dl. Platelets ≥ 100,000/µL. Serum creatinine ≤ 1.5 upper limit of normal (ULN). Serum bilirubin ≤ ULN. AST/ALT ≤ 1.5 x the ULN.
• •Patients must be able to swallow capsules.
• •Patients must give written informed consent before study participation.
• •No history of another cancer within the past 5 years (except basal or squamous cell carcinoma of the skin).
• •No brain or leptomeningeal metastases.
• •Female patients must not be pregnant or lactating and must be willing to practice contraception. Males must agree to contraceptive practices.
• •For HRPC cohort
• •Patient must continue to be administered an LHRH agonist if they were receiving it at the time of screening for entry onto this protocol. Patients who have undergone bilateral orchiectomy do not need to be on LHRH agonists.
• •Patient must be off of anti-androgen medications for ≥ 6 weeks.
• •Patient must have castrate level of testosterone (\< 50 ng/dL).
• •Progressive HRPC as defined by one of the following:
• •* Rising PSA
• •* Sequential imaging studies
• •* Clinical suspicion in the view of the treating physician