@entity3003 plus XXXX with concomitant radiation therapy in advanced @entity1149 : a phase I study.

@entity1 @entity137 @entity5 @entity3003 @entity2910 @entity1149 @entity900 @entity1206 @entity1398 @entity1207
This phase I study was designed to determine the maximum tolerated dose of @entity3003 when administered in combination with a fixed dose of @entity1206 and concomitant radiation therapy in @entity1 with advanced @entity1149 . Chemotherapy was administered on days 1 and 8 of two 21 day cycles. It consisted of @entity1206 at 15 mg/m(2) and @entity3003 administered at an initial area under the curve (AUC) of 1.5, and increased by an AUC of 0.5 per dose level to a maximum AUC of 3, corresponding with an AUC of 6 per cycle of chemotherapy. Radiation was administered in daily fractions of 200 cGy over 5-7 weeks. We treated 36 @entity1 , of whom 27 had @entity5 , and nine had stage IV disease but required thoracic radiation for palliation. @entity137 included @entity1398 (three with Grade 4) and @entity2910 (seven with Grade 3 and one with Grade 4). Four @entity1 had @entity1207 4-7 months after completing therapy, three of whom died. The recommended phase II dose of @entity3003 is an AUC of 3 on 2 consecutive weeks. Of 33 @entity1 evaluable for response within the radiation field, 17 (52%) had complete or partial response, and 13 had stable disease. Of seven @entity1 evaluable with distant metastatic disease, three had a complete or partial response, and two had stable disease. The median survival for the entire group and for @entity1 with @entity5 was 13.5 months. We conclude that the combination of @entity3003 , @entity1206 , and radiotherapy is feasible at these doses. It may be a useful alternative for @entity1 not able to tolerate @entity900 -based therapy.
