PURPOSE: @entity1206 and @entity1205 are two active agents in the treatment of metastatic @entity0 . When given together, these drugs exhibit synergistic antitumor activity without significant pharmacokinetic interaction. The dose-limiting @entity137 of this combination are @entity221 and @entity33 . Adding @entity1261 ( @entity1261 ) might lessen the @entity137 and increase the maximum tolerated dose (MTD) of this combination. The aim of this study was to determine the MTD of @entity1206 and @entity1205 given in combination with @entity1261 . @entity1 AND METHODS: Between August 1997 and December 1998, 14 @entity1 with metastatic @entity0 were enrolled in this study. All @entity1 had received @entity632 -based therapy, and 46% had received @entity1311 in the adjuvant or neoadjuvant setting. @entity1 were treated with @entity1206 at a starting dose of 20 mg/m2 intravenously over 10 min on days 1 and 5 and @entity1205 at a starting dose of 85 mg/m2 intravenously over 1 hr on day 1, following the @entity1206 . Treatments were repeated every 21 days. Prophylactic @entity1261 5 mcg/kg was given subcutaneously on days 3-10. @entity137 was graded according to the National @entity5 Institute's grading system. RESULTS: A total of 65 cycles was administered at dose levels 0, -1, -2, and -3. The median absolute granulocyte count nadir for all courses was 200 mm(-3) (range, 0.1-7700 mm(-3)), and the median time to this nadir was 9 days (range, 7-30). The median platelet nadir was 163 (range, 27-401 k), and the median time to this nadir was 8 days (range, 7-30). The most common grade 3 nonhematologic @entity137 for all courses were @entity1295 and @entity925 , which occurred in 32 and 10 cycles, respectively. @entity221 was encountered in 11 cycles. Three @entity1 developed @entity1960 -like pictures, two of whom died as a result. Consequently, the protocol was closed to accrual before a MTD was reached. CONCLUSION: The combination of @entity1206 , @entity1205 , and @entity1261 in our hands has proven to be a toxic regimen, even when relatively low doses of @entity1206 and @entity1205 are given. Meticulous observation of @entity1 receiving this combination is warranted since the combination resulted in two deaths in this study.

Phase I study of @entity1206 and XXXX with @entity1261 support in the treatment of metastatic @entity0 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'PATIENTS'] @entity632 :: ('MESH:D004317', 'Chemical') :: ['doxorubicin'] @entity137 :: ('MESH:D064420', 'Disease') :: ['Toxicity', 'toxicities', 'toxicity'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer'] @entity1261 :: ('1440', 'Gene') :: ['granulocyte colony-stimulating factor', 'G-CSF'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer'] @entity33 :: ('MESH:D052016', 'Disease') :: ['mucositis'] @entity1205 :: ('MESH:C067311', 'Chemical') :: ['docetaxel'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel'] @entity1206 :: ('MESH:C030852', 'Chemical') :: ['vinorelbine', 'Vinorelbine'] @entity1295 :: ('MESH:D005221', 'Disease') :: ['fatigue'] @entity1960 :: ('MESH:D003092', 'Disease') :: ['colitis'] @entity925 :: ('MESH:D063806', 'Disease') :: ['myalgia'] @entity221 :: ('MESH:D005334', 'Disease') :: ['neutropenic fever', 'Neutropenic fever']
@entity1205 :: (MESH:C067311,Chemical) :: ['docetaxel']
