Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors

Exclusion Criteria

• •Metastatic brain or meningeal tumors (unless subject completed definitive therapy more than 1 month previously and is stable off steroids).
• •Uncontrolled hypertension defined as systolic blood pressure \> 140 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
• •Active or clinically significant cardiac disease including:
• •* Congestive heart failure - New York Heart Association (NYHA) \> Class II.
• •* Active coronary artery disease.
• •* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
• •* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
• •Subject with any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 2 or higher within 4 weeks of study enrollment; any other hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 3 or higher within 4 weeks of study enrollment.
• •Major surgery, open biopsy or significant traumatic injury within 30 days of first study drug.
• •Presence of an active non-healing wound, non-healing ulcer, or bone fracture.
• •Thrombotic or embolic events such as a cerebrovascular accident (including transient ischemic attacks) within 3 month of informed consent.
• •Anticoagulation with warfarin is not permitted.
• •Evidence or history of bleeding diathesis or coagulopathy.
• •Subjects who have used strong CYP3A4 inducers (eg, phenytoin, carbamazepine, phenobarbital, St. John's Wort \[Hypericum perforatum\], dexamethasone at a dose of greater than 16 mg daily, or rifampin \[rifampicin\], and/or rifabutin) within 30 days of trial enrollment.
• •Subjects with a history of dihydopyrimidine dehydrogenase (DHPD) deficiency or severe and unexpected reactions to fluropyrimidines.
• •Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed. All relevant cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form).
• •History of organ allograft. (Including corneal transplant).
• •Known human immunodeficiency virus (HIV) infection or Hepatitis B or C currently undergoing active antiviral treatment.
• •Any malabsorption problem.
• •Anticancer chemotherapy or immunotherapy during the study is not permitted.
• •Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
• •Women who are pregnant or breast-feeding.
• •Inability to comply with the protocol and/or not willing or not available for follow-up assessments.
• •Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.