Eastern Cooperative Oncology Group (ECOG) performance status - as documented within months prior to study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of to at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< study entry Eastern Cooperative Oncology Group (ECOG) performance status - at time of study entry Eastern Cooperative Oncology Group (ECOG) performance status of - at study entry Eastern Cooperative Oncology Group (ECOG) performance status of to at trial entry Eastern Cooperative Oncology Group (ECOG) performance status of =< study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry STEP ENROLLMENT AND RANDOMIZATION: the patients Eastern Cooperative Oncology Group (ECOG) performance status is =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status to within days of study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of =< at study entry Eastern Cooperative Oncology Group (ECOG) performance status of - at study entry Eastern Cooperative Oncology Group (ECOG) performance status to within days of study entry