Erlotinib and Sorafenib in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Exclusion Criteria

• •Patients with serious concurrent infection or medical illness which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety; (examples of medical illnesses are \[but not limited to\] the following: uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements)
• •Patients with uncontrolled hypertension; hypertension with systolic blood pressure of \> 140 mmHg or diastolic pressure \> 90 mmHg; however, patients with well-controlled hypertension are eligible
• •Patients who are pregnant or breast-feeding (the anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant)
• •Patients who have received more than two prior treatments
• •Patients who have had prior therapy with erlotinib or sorafenib or any other agent targeting EGFR
• •Patients receiving concurrent therapy for their tumor (with the exception of steroids)
• •Patients undergoing major surgery or sustaining a significant traumatic injury within 21 days prior to treatment are ineligible
• •Patients with a concurrent malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin; patients with a prior malignancy are ineligible unless they have been free of disease for \>= five years
• •Patients must not have any evidence of bleeding diathesis or coagulopathy
• •Patients with PT INR \> 1.5 are excluded, unless the patient is on full dose warfarin
• •Patients on full-dose anticoagulants (e.g., warfarin) are eligible provided that both of the following criteria are met:
• •* The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
• •* The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
• •* NOTE: Patients on a full dose of anticoagulants will a different schedule for PT/INR evaluations
• •Prophylactic anticoagulation (i.e. low dose warfarin) are eligible provided their coagulation parameter levels are as follows: prothrombin time (INR; International Normalized Ratio of prothrombin time) \< 1.1 x institutional upper limit of normal
• •Patients with known abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test) are excluded
• •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 are excluded
• •Patients cannot be receiving cytochrome P450-inducing anticonvulsants (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) and must not have taken them for at least 10 days
• •Patients may not have allergies to or a history of allergic reactions attributed to erlotinib and/or sorafenib
• •Eligibility of patients receiving any other medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of erlotinib or sorafenib will be determined following review of their case by the Principal Investigator
• •HIV patients receiving combination anti-retroviral therapy will be excluded