SWOG 9717:EVALUATION OF INTRAVENOUSLY ADMINISTERED TIRAPAZAMINE + CIS

本研究的目的是确定替拉帕明和顺铂联合治疗晚期宫颈癌的有效性。目前，宫颈癌是美国女性第四大常见恶性肿瘤，也是妇科恶性肿瘤的第二大死因。初次治疗后难治性或复发的宫颈癌的治疗结果仍然令人失望。因此，正在进行研究，以确定更有效的化疗方案来治疗这种疾病。这种癌症是一种相对耐化疗的肿瘤，其疗效通常会因先前放射治疗的并发症而进一步降低。此外，巨大的肿瘤肿块和糟糕的血液供应往往会导致很大比例的肿瘤细胞处于缺氧环境，这限制了大多数标准化疗药物的疗效。替拉帕扎明是一种研究性化疗药物，专门开发用来增强对缺氧细胞的活性。本研究旨在研究顺铂联合替拉帕明治疗复发或难治性宫颈癌患者的疗效和毒性。

The purpose of this study is to determine how effective treatment with tirapamine and cisplatin is in treating advanced cervical cancer. At present, cervical cancer is the fourth most common malignancy in American women, and the second leading cause of death from gynecologic malignancy. Therapeutic outcome for cervical carcinoma which is refractory or recurrent following primary therapy remains disappointing. Thus, research is ongoing to identify more effective chemotherapeutic regimens for this disease. This cancer is a relatively chemoresistant tumor, and the efficaicy is often further diminished by complications of prior radiation therapy. Additionally, the contribution of bulky tumor masses and poor blood supply often results in a hypoxic environment for a large percentage of tumor cells which limits the efficacy of most standard chemotherapeutic agents. Tirapazamine is an investigational chemotherapeutic agent which was specifically developed to have increased activity against hypoxic cells. The present study has been designed to study the efficacy and toxicities associated with a combination of cisplatin plus tirapazamine administered every 21 days in patients with recurrent or refractory cervix cancer.