Of 60 patients registered, 1 patient was not treated because of ECOG PS outside inclusion criterion on day 1 of cycle 1; 6 remaining patients were not evaluable because of intercurrent illness or injury (n = 1 lower extremity edema and n = 1 pathologic fracture of the femur) and n = 1 each disease progression, administration of prohibited concomitant medication, thrombocytopenia, and investigator decision that local radiotherapy would be a preferred treatment option.

Median time to response (n = 7) was 1.4 months (range, 1.2-5.3 months). Median duration of response was 7.9 months (range, 2.8-22.4 months).

Includes 11 with SD > 6 months.