PHASE I TRIAL TO DETERMINE MTD OF IRONOTECAN IN ADVANCED CANCER

该方案是确定最大耐受量的I期试验。 晚期癌症患者CPT-11的MTD测定进行了治疗 每三周一次。到目前为止，已有35名患者入选， 我们已确定无病史患者的MTD为320毫克/平方米。 腹部/盆腔放射治疗。对于先前接受过放射治疗的患者 治疗后，MTD略低，为290 mg/m2。剂量限制 该方案的毒性是胃肠道反应(恶心， 呕吐、腹泻)和血液病(主要是中性粒细胞减少症)。这个 目前的临床信息正在与 药物动力学。该协议的摘要已经发表， 手稿已经准备好了。给出了CPT-11的未来研究 每三周一次的给药计划将评估患者 其他晚期肿瘤(例如乳腺癌、胃癌和脑 肿瘤)。CPT-11也正在与其他试剂联合评估 耐受性和有效性。

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.