PHASE I TRIAL TO DETERMINE MTD OF IRONOTECAN IN ADVANCED CANCER

本方案为I期试验，旨在确定最大耐受剂量 (MTD)CPT-11在晚期癌症患者中的应用 给予治疗 每三周一次。 迄今为止，已招募了35名患者， 我们已经确定，对于没有既往病史的患者， 腹部/盆腔放射治疗。 对于既往接受过放疗的患者 治疗中，MTD略低，为290 mg/m2。 剂量限制 该方案的毒性是胃肠道的（恶心， 呕吐和腹泻）和血液学（主要是中性粒细胞减少症）。 的 沿着分析当前的临床信息， 药代动力学 该方案的摘要已发表， 手稿也准备好了 CPT-11的未来研究 每三周一次的给药方案将评估以下患者 其他晚期肿瘤（如乳腺癌、胃癌和脑癌） 肿瘤）。 CPT-11还与其他药物联合使用， 耐受性和功效。

This protocol is a phase I trial to determine the maximum tolerated dose (MTD) of CPT-11 in patients with advanced cancer. Treatment is given once every three weeks. To date, 35 patients have been enrolled, and we have determined that the MTD is 320 mg/m2 for patients with no prior abdominal/pelvic radiation therapy. For patients with prior radiation therapy, the MTD is slightly lower at 290 mg/m2. Dose limiting toxicities on this protocol have been gastrointestinal (nausea, vomiting, and diarrhea) and hematologic (primarily neutropenia). The current clinical information is being analyzed along with the pharmacokinetics. An abstract from this protocol has been published, and the manuscript is prepared. Future investigations of CPT-11 given on an every-three-week dosing schedule will be assessing patients with other advanced tumors (e.g. breast cancer, gastric cancer, and brain tumors). CPT-11 is also being combined with other agents to assess tolerability and efficacy.