Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases

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 dose-limiting adverse events due to agents administered more than 4 weeks earlier.
• •2. Patients may not be receiving any other investigational agents or hormonal therapy besides that used to maintain medical castration. Glucocorticoid therapy for intercurrent medical illnesses such as asthma, Chronic Obstructive Pulmonary Disease (COPD) or rheumatoid arthritis flare will be allowed.
• •3. Patients may not be co-medicated with an agent that causes QTc prolongation.
• •4. Patients with a mean QTc \>500msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome are ineligible.
• •5. Left ventricular ejection fraction (LVEF) \<40%.
• •6. Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
• •7. Ongoing vomiting, or nausea \>/= Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0). If nausea, or vomiting is controlled with therapy (and therefore not Grade 2) such patients may be enrolled.
• •8. Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow pills or absorb oral medications are excluded.
• •9. History of chronic liver disease.
• •10. Known or suspected primary muscular or neuromuscular disease (e.g., muscular dystrophy, myasthenia gravis).
• •11. History of allergic reactions attributed to compounds of similar chemical or biologic composition to tandutinib. Patients who develop an acneiform/maculopustular rash while taking either gefitinib or erlotinib should not be prevented from receiving tandutinib unless the rash is considered an allergic reaction (angioedema/urticaria) or Stevens-Johnson syndrome.
• •12. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• •13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infections defined as requiring IV antibiotics on Day 1 of treatment or psychiatric illness/social situations that would limit compliance with study requirements.
• •14. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with TANDUTINIB. 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.