 - Documented evidence of a tumor response of CR, PR, or SD. Tumor assessment must occur between Cycle 4 Day 1 of induction therapy and the date of randomization. Tumor assessment will be per RECIST Appendix 3 by the treating physician. This response does not have to be confirmed in order for the patient to be randomized; however, unconfirmed responses will be stratified in the stable disease strata. Positron emission tomography PET scans and ultrasound may not be used for lesion measurements for response determination 