Study of Satraplatin With Capecitabine to Treat Advanced Solid Malignancies

Exclusion Criteria

• •Other chemotherapy treatment \< 4 weeks prior to enrollment Treatment with capecitabine, 5-fluorouracil (5-FU), or a platinum agent \< 3 months from time of enrollment
• •Radiotherapy involving \> 30% of the active bone marrow
• •Radiotherapy \< 4 weeks prior to enrollment
• •Pre-existing peripheral neuropathy \> grade 1
• •Pre-existing hearing loss \> grade 2
• •Metastatic brain or meningeal tumors unless the patient is \> 6 months from definitive therapy, had a negative imaging study within 4 weeks of study entry, is clinically stable with respect to the tumor at the time of study entry, and is not receiving steroid therapy or taper
• •Patients who have not recovered (\> grade 1) from the following toxicities of previous regimens before enrollment:
• •* hematologic toxicities
• •* fatigue
• •* mucositis
• •* nausea/vomiting
• •* diarrhea
• •Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation)
• •Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
• •History of hypersensitivity reaction to capecitabine, 5-FU or any platinum containing drugs
• •History of human immunodeficiency (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
• •Evidence of concurrent second malignancy other than basal cell carcinoma of the skin or cervical carcinoma in situ
• •Concurrent use of medications that inhibit cytochrome P450 3A4 (including aprepitant)
• •History of bone marrow or major organ transplant