A Phase I Study of Weekly Topotecan With Cisplatin for the Management of Advanced Stage or Recurrent Carcinoma of the Cervix
Patients diagnosed with recurrent cervical cancer generally have limited options for cure.
Occasionally, radiation therapy may be utilized in localized recurrent disease with curative
intent; however, most patients are not candidates for curative therapy secondary to
disseminated disease, and thus are frequently treated with palliative chemotherapy. Initial
experiences with chemotherapy in this clinical setting demonstrated cisplatin to be an
active agent. Subsequent trials using combinations of cisplatin and ifosfamide or
paclitaxel demonstrated higher response rates compared to cisplatin alone but did not
demonstrate an improvement in overall survival. Topotecan is a topoisomerase I inhibitor
that has been used in the management of cervical and ovarian cancer. Several phase II
studies have demonstrated topotecan to be an active agent in cervical cancer. In an effort
to ameliorate toxicity noted with 3-5 day dosing regimens of topotecan, investigators have
evaluated weekly dosing of topotecan. Thus far, the toxicity of weekly topotecan dosing in
cervical cancer has not been evaluated. In this study, topotecan will be given weekly at
escalating dose levels starting at 2.0 mb/m2 with standard cisplatin at 50 mg/m2 every 21
days. This study will help to determine acceptable dosing for the combination of weekly
topotecan and cisplatin in patients with persistent, recurrent, or advanced stage cervical
cancer which can then be utilized in a cohort of patients with cervical cancer in a phase II
study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of topotecan when given weekly with cisplatin
J. Michael Straughn, Jr., MD
Principal Investigator
University of Alabama at Birmingham
United States: Institutional Review Board
104799
NCT00322920
July 2005
Name | Location |
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University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |