Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC

Exclusion Criteria

• •History of treatment of TCC (in any setting-neoadjuvant, adjuvant or for metastatic disease) with docetaxel. Patients treated with prior paclitaxel (Taxol) are eligible.
• •History of treatment with a VEGF-axis active agent, including antibodies to VEGF, antibodies to VEGF receptors, or VEGF receptor tyrosine kinase inhibitors.
• •Laboratory results as outlined in the protocol
• •Evidence of uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
• •Clinically significant cardiac event such as myocardial infarction; NHYA classification of heart disease \>2 within three months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia
• •History of arrhythmia, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation which is symptomatic or requires treatment (CTCAE Grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
• •Previous history of QTc prolongation as a result from other medication that required discontinuation of that medication.
• •Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
• •Presence of left bundle branch block (LBBB)
• •QTc with Bazett's correction that is unmeasurable, or 480 msec or greater on screening ECG. If a subject has a QTc of 480msec or greater on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be \<480 msec in order for the subject to be eligible for the study.
• •Any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes or induce CYP3A4 function.
• •Hypertension not controlled by medical therapy
• •Currently active diarrhea
• •Women who are currently pregnant or breast feeding
• •Receipt of any investigational agent, chemotherapy or radiation therapy within 21 days prior to Study Day 1
• •Any unresolved non-hematologic toxicity greater than CTCAE grade 1 from previous anti-cancer therapy (other than alopecia).
• •Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
• •Grade 2 or greater peripheral neuropathy
• •Previous or current malignancies within the last 3 years, with the exception of in situ carcinoma of the cervix, adequately treated carcinoma of the skin, small renal masses, and adequately treated localized prostate cancer. Other cancers that are highly likely to be cured (cure rate of 75% or greater) may be included at the discretion of the Overall Principal Investigator.
• •History of severe hypersensitivity reaction to drugs formulated with polysorbate 80.