A phase I study of XXXX concurrent with @entity1161 in FIGO stage IIIB cervix uteri carcinoma.

@entity1 @entity137 @entity5 @entity3003 @entity1161 @entity900 @entity1398 @entity1431
PURPOSE: Chemoradiation based on @entity900 , most commonly weekly, is the standard treatment of locally advanced cervical @entity5 ; however, the nephrotoxic potential and the requirement for hydration of @entity900 somewhat restrains its use. The objective of this study was to determine the recommended dose of @entity3003 when administered weekly during pelvic @entity1161 ( @entity1161 ). METHODS AND MATERIALS: Twenty-four histologically proven, International Federation of Gynecology and Obstetrics Stage IIIB @entity1 were treated with standard pelvic @entity1161 concurrently with six weekly applications of @entity3003 at the following dose levels: 100 mg/m(2), 116 mg/m(2), 133 mg/m(2), and 150 mg/m(2). Six @entity1 per level were treated. Acute @entity137 was assessed according to the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria. The recommended dose was defined as the one that was one level below the level at which dose-limiting @entity137 was present in more than one-third of @entity1 . RESULTS: Between September 2001 and July 2002, 24 @entity1 were accrued. All but two completed external beam radiotherapy and intracavitary treatment. The treatment was well tolerated. The median number of weekly applications of @entity3003 was six, and the mean dose to points A and B was 85.6 Gy (range 75.2-91.6) and 62.9 Gy (range 58.2-74.6), respectively. @entity1161 was delivered within 41.7 days (range 33-70). Dose-limiting @entity137 ( @entity1431 and/or @entity1398 ) was present in 50% of @entity1 treated at the higher dose level (150 mg/m(2)). At the recommended dose of 133 mg/m(2), 33% of @entity1 presented with Grade 3 @entity1431 . At treatment completion, 75% of @entity1 had a complete clinical response. CONCLUSION: @entity3003 at 133 mg/m(2), weekly for 6 weeks, is a well tolerated and effective radiosensitizer in cervical @entity5 @entity1 .
