OBJECTIVE: The goal of this study was to evaluate the efficacy and tolerability of @entity2600 plus @entity900 as first-line chemotherapy in metastatic or recurrent @entity5 . METHODS: Chemotherapy-naive @entity1 with metastatic or recurrent disease and at least one measurable @entity5 site received @entity2600 (60 mg/m(2) IV infusion over 90 min) on Days 1, 8, and 15, followed by @entity900 (60 mg/m(2) IV over 90 min) on Day 1, every 28 days for a maximum of six cycles. RESULTS: Thirty @entity1 were included in the response and @entity137 analysis. The median age was 45 years (34-65). Nineteen @entity1 had @entity3 , 6 presented with locally recurrent disease, and 5 presented with locally recurrent plus @entity3 . Seven @entity1 were stage IVB at diagnosis. There were 2 complete and 18 partial responses and overall response rate was 66.7% (95% confidence interval: 47-85%). Stable disease was observed in 2 @entity1 (6.7%) and progression in 8 (26.7%). Median time to relapse was 13.4 months, with a median survival time of 16.9 months. One-year disease-free survival and overall survival were 26.7 and 65.1%, respectively. Dose-limiting @entity137 was observed in 4 @entity1 (13.3%) with grade 3 @entity8 . Nine @entity1 (30%) developed grade 3 @entity1398 , and only grade 1-2 acute and late @entity294 were observed in 20 and 40%, respectively. A @entity1 developed pancolitis after the sixth cycle. There were no chemotherapy-related @entity204 . CONCLUSION: The combination of @entity2600 and @entity900 is a clinically active regimen for metastatic and/or recurrent @entity5 with acceptable tolerability.

Phase II clinical study of XXXX and @entity900 as first-line chemotherapy in metastatic or recurrent @entity5 .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity8 :: ('MESH:D007674', 'Disease') :: ['renal toxicity'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity2600 :: ('MESH:C051890', 'Chemical') :: ['irinotecan'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'cervical cancer'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastatic disease'] @entity204 :: ('MESH:D003643', 'Disease') :: ['deaths']
@entity2600 :: (MESH:C051890,Chemical) :: ['irinotecan']
