Key

Inclusion Criteria:

- Histologically confirmed solid tumor that is metastatic or unresectable and for which
standard curative or palliative chemotherapy measures do not exist or are no longer
effective

- Age > 18 years old

- ECOG Performance Status < 2

- Female patients may not be pregnant or lactating and must be willing to practice
contraception

- Adequate organ function as defined by the following:

- Serum creatinine < 1.5 mg/dl

- Absolute neutrophil count (ANC) > 1500/dL

- Platelets > 100,000/dL

- Total bilirubin < upper limit of normal (ULN) for the reference lab

- AST, ALT, and alkaline phosphatase must be within the designated range allowing
for eligibility

Key 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