| Exclusion Criteria: | 1) Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
2) Patients may not be receiving any investigational agents other than BAY 43-9006 and R115777
3) Patients with known brain metastases are excluded except for patients who have had treated brain metastases and are currently not taking anti-seizure medications or steroids.
4) Patients may not have allergies to imidazoles (e.g., clotrimazole, ketoconazole, miconazole, econazole) or a history of allergic reactions attributed to any other compound of similar chemical or biologic composition to either BAY 43-9006 or R115777
5) Uncontrolled hypertension with systolic blood pressure of >140 mmHg or diastolic pressure >90 mmHg. However, patients with well-controlled hypertension are eligible
6) Patients must not have any evidence of current history of bleeding diathesis.
7) Patients may not have grade 2 or greater peripheral neuropathy
8) Patients with any condition that impairs their ability to swallow pills are excluded
9) Patients cannot be receiving EIAEDs (e.g., phenytoin, carbamazepine, phenobarbital) nor any other CYP3A4 inducer such as rifampin or St. John's wort
10) Uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
11) Patients with a NYHA classification >2
12) Pregnant women are excluded from this study because BAY 43-9006 is a tyrosine kinase inhibitor and R115777 is a farnesyl transferase inhibitor, both of which have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BAY 43-9006 or R115777, breastfeeding should be discontinued if the mother is treated with either of these agents
13) HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with BAY 43-9006 and/or R115777. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated |