Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients with Recurrent or Metastatic Head and Neck Cancer

Pts must have hist proven SCCHN that is either met at dx or persisted, met or recurred following definitive surg and/or RT and is not amenable to surg resection. Pts with newly diagnosed non-met dz not elig. Pts must be willing to submit archived tissue speciment for IHC correlative studies. Pts must not have rec'd prior chemo, for recurrent or newly diagnosed met dz. Pts who have rec'd induction or adjuvant chemo are eligible provided at least 6 mos has elapsed since last course of chemo was administered. Pts may have rec'd only one induction or adjuvant regimen. Prior RT & surg must have been completed at least 28 days prior to reg & all toxicites/complications/AEs resolved. Must have measurable dz & must be assessed w/i 28 days prior to reg. If also non-measurable dz, must be assessed w/i 42 days prior to reg. Pts whose only measurable dz is w/i a previous RT port must demonstrate clear progressive dz prior to reg. Must not be planning to rec any other concurrent therapy for SCHHN while on study. PS 0 -1. Must not have active infection requiring systemic therapy, no active or prior CNS mets. Must have adequate hematologic values, renal function & hepatic function. Must not have significant history of cardiac dz w/i last 6 mos or cardiac ventricular arrhythmias requiring meds. Must not have any evidence of bleeding diathesis. Must not be on therapeutic anticoagulation. Must be able to take oral meds w/o crushing, dissolving or chewing. Must not be pregnant or nursing; women/men of reproductive potential must agree to use an effective contraceptive method.