ECOG < 2 ECOG of 0-1 at screen ECOG ? 2 ECOG ? 1 Patient with ECOG ? 2 ECOG 0-2 ECOG 0 or 1 ECOG 0 or 1 ECOG 0-2 PART II: ECOG 0-1 ECOG 3 - 4 ECOG 0 or 1 ECOG 0 or 1 ECOG of 0 or 1 ECOG 0-2 ECOG ?2. Patient with ECOG ? 2 ECOG 0,1 ECOG 3 or 4 ECOG ? 1 ECOG of 0 to 1 ECOG ?2. ECOG 0 or 1 ECOG ? 2 ECOG 0 or 1 ECOG 0 to 2 ECOG=2 or better ECOG of 0 or 1 ECOG of 0 or 1. ECOG ? 2. ECOG 0-1 ECOG 0 or 1 ECOG ? 2 ECOG 0, 1 or 2 ECOG of 0 or 1 ECOG > 2 ECOG 0 or 1 at enrolment. ECOG 0, 1, or 2