@entity900 in combination with either @entity136 or XXXX in @entity189 of unknown primary site: results of a randomized phase II study--trial for the French Study Group on @entity189 of Unknown Primary (GEFCAPI 01).

@entity1 @entity137 @entity2600 @entity900 @entity189 @entity136
PURPOSE: To evaluate the efficacy and @entity137 of novel chemotherapy combinations including @entity900 with @entity136 (GC) or @entity2600 (IC) for @entity1 with @entity189 of an unknown primary site. @entity1 AND METHODS: Eighty @entity1 were randomly assigned to receive GC or IC. In the GC arm, chemotherapy consisted of cycles combining @entity136 1,250 mg/m2 intravenously (IV) on days 1 and 8, and @entity900 100 mg/m2 IV on day 1 at 3-week intervals. @entity1 in the IC arm originally received 3-week cycles of @entity2600 200 mg/m2 IV on day 1 and @entity900 80 mg/m2 IV on day 1. After the inclusion of 15 @entity1 in that arm, the @entity137 profile required the @entity2600 doses to be reduced to 150 mg/m2 per cycle. Independent histologic and radiologic reviews were done. RESULTS: A total of 78 @entity1 were assessable for efficacy and @entity137 . The median number of cycles was four in each arm. Objective responses were observed in 21 @entity1 (55%) in the GC arm (95% CI, 34% to 66%) and in 15 @entity1 (38%) in the IC arm (95% CI, 23% to 54%). Treatment had to be stopped because of @entity137 in seven @entity1 in the GC arm and in eight @entity1 in the IC arm. With a median follow-up of 22 months, the median survivals were 8 and 6 months in the GC and IC arms, respectively. CONCLUSION: This study demonstrates the activity of both the GC and IC regimens. There was @entity137 associated with both regimens. Additional studies of combination chemotherapy regimens are required.
