BAY 12 9566 IN COMBINATION W/ ETOPOSIDE & CARBOPLATIN IN CANCER PATIENTS

BAY 12-9566是一种基质金属蛋白酶抑制剂（MMPI），最近在马约诊所进行了I期试验。 它的主要作用是防止胶原蛋白基质的分解，从而防止癌症的扩散。 在使用小鼠异种移植模型的临床前研究中，BAY 12-9566增加了依托泊苷的抗肿瘤作用。 类似的活动已经注意到与其他药物，包括顺铂。 因此，本研究的目的是确定BAY 12-9566/依托泊苷/卡铂组合的最大耐受剂量。 一旦确定MTD，该组合将用于肺癌的II期研究。在本研究中，将在一组无其他标准或潜在治愈性治疗的晚期癌症患者中确定耐受性、药代动力学和抗肿瘤活性。将对接受BAY 12-9566/依托泊苷的患者和接受BAY 12-9566/依托泊苷/卡铂的患者进行药代动力学研究。 每组共入组6例患者。

BAY 12-9566 is a matrix metalloproteinase inhibitor (MMPI) which has recently undergone phase I testing at the Mayo Clinic. Its primary action is to prevent the breakdown of the collagen matrix and thus prevent the spread of cancer. In preclinical studies using a mouse xenograft model BAY 12-9566 increased the antitumor effect of etoposide. Similar activity has been noted with other antineoplastic drugs including cisplatin. As such it is the goal of this study to determine the maximum tolerated dose of the combination of BAY 12-9566/etoposide/carboplatin. Once the MTD has been determined, this combination will then be used in a phase II study of lung cancer. In the present study, tolerability, pharmacokinetics, and antitumor activity will be determined in a group of patients with advanced cancer for whom no other standard or potentially curative treatments are available. Pharmacokinetics will be studied for patients' receiving BAY 12-9566/etoposide and for those receiving BAY 12-9566/etoposide/carboplatin. A total of 6 patients will be enrolled into each group.