BACKGROUND: The purpose of this study was to determine the maximum-tolerated dose (MTD) and the antitumor activity of @entity136 when administered in combination with concurrent @entity900 and radiotherapy in locally advanced @entity2622 (LACC). @entity1 AND METHODS: @entity1 with histologically confirmed LACC (International Federation of Gynecology and @entity3480 ), previously untreated, were eligible for entry in the study to receive radiotherapy and concomitant weekly chemotherapy with @entity900 40 mg/m(2) and @entity136 at increasing doses levels until the MTD was found. RESULTS: Thirty-six @entity1 were included. Sixteen @entity1 were entered at four dose levels. The MTD was 150 mg/m(2) and the recommended dose of @entity136 for phase II was 125 mg/m(2). Twenty additional @entity1 were entered at this level. @entity137 at the recommended dose was acceptable with grade 3/4 @entity137 in <20% of @entity1 . Thirty-five of thirty-six @entity1 (97.3%) achieved an objective response, 32 (88.8%) a complete response (CR) three a (8.3%) partial response and one (2.7%) stable disease. At a median follow-up of 26 months, 28 of 36 @entity1 (77.7%) are in sustained complete remission and seven of 36 (19.4%) have relapsed. The 3-year disease-free and overall survival rates are 67% and 72%, respectively. CONCLUSION: The association of @entity900 and @entity136 with concurrent radiotherapy is active and well-tolerated in untreated LACC.

A phase I-II study of weekly XXXX and @entity136 with concurrent radiotherapy in locally advanced @entity2622 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'Toxicity'] @entity3480 :: ('MESH:C538167', 'Disease') :: ['Obstetrics IIB-IVA'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity2622 :: ('MESH:D002583', 'Disease') :: ['cervical carcinoma'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['gemcitabine']
@entity900 :: (MESH:D002945,Chemical) :: ['cisplatin']
