Phase II study of @entity1311 plus XXXX in @entity2971 (E9897): a trial of the Eastern Cooperative Oncology Group.

@entity1 @entity137 @entity2971 @entity5 @entity221 @entity1311 @entity136
PURPOSE: Despite great success in the treatment of disseminated germ cell @entity5 , 20% of @entity1 are incurable and become candidates for investigational therapy. @entity1311 and @entity136 have shown activity as single agents in @entity2971 and can be combined with manageable @entity137 . @entity1 AND METHODS: @entity1 with germ cell @entity5 believed to be incurable with chemotherapy or surgery were treated with @entity1311 110 mg/m(2) and @entity136 1,000 mg/m(2) intravenously on days 1, 8, and 15 of a 4-week cycle for a maximum of six cycles. @entity1 were evaluated for response and @entity137 . RESULTS: Twenty-eight of 30 enrolled @entity1 were assessable. @entity137 was primarily hematologic but was manageable with only a single case of @entity221 . Six (21.4%) of 28 @entity1 responded, including three complete responses. Two of the complete responders were continuously disease-free at 15+ and 25+ months. CONCLUSION: @entity1311 plus @entity136 is an active regimen in @entity2971 , with an acceptable @entity137 profile. This regimen has the possibility for long-term disease-free survival in this refractory @entity1 population.
