The subject has a KPS ? Subject has a KPS ? . KPS of ? or ECOG of to Modified KPS of < % KPS ? KPS >= % KPS >= % KPS performance >= % Patients must have KPS >/= KPS Score < (See \Definitions\ below) KPS equal to or greater than KPS < RPA class III (KPS < ) Patients must have a Karnofsky performance status (KPS) rating of >= prior to initiating treatment; patients may be enrolled at a KPS of < if it is felt that the patient will have adequate opportunity to recover to a KPS >= by the initiation of treatment KPS > KPS % or greater KPS ?. KPS must have been stable during the period from wash-out of prior therapy to randomization. A declining KPS is defined by reduction of points or more over at least a -day period. Modified KPS of < % KPS or worse KPS equal to or greater than KPS >/= KPS % or higher KPS> Have KPS of ?% KPS < RPA class III (KPS < %) KPS: at least KPS Score < (See \Definitions\ below) Has a KPS score of >= KPS < %