Phase I Dose Escalation Study Of Weekly Paclitaxel and Cisplatin Followed by Radical Hysterectomy in FIGO IB2 and Bulky IIA Cervical Cancer
This is a multi-center, open-label, phase I study of paclitaxel and cisplatin as neoadjuvant
therapy in patients with FIGO IB2 or bulky IIA, squamous cell cervical carcinoma of the
uterine cervix.
The study is mainly for the dose-finding of paclitaxel, combining with a fixed cisplatinum
dose, as neoadjuvant chemotherapy on a weekly basis. The optimal dose of paclitaxel is
principally defined as the highest dose that allow at least 5/6 patients, after NAC, to
undergo scheduled radical hysterectomy. A subsequent toxicity assessment to evaluate the
impact of this neoadjuvant chemotherapy to the recovery of the following radical
hysterectomy, and efficacy assessment is set as the second purpose of this study.
Primary Objectives:
- to establish an optimal dose of weekly cisplatin plus paclitaxel for 3 cycles as
neoadjuvant chemotherapy (NAC) for FIGO IB2 and bulky IIA, squamous cell cervical
cancer, followed by radical hysterectomy and pelvic lymphadenectomy
Secondary Objectives:
- to evaluate the toxicity of the study regimen and its impact to the radical
hysterectomy after neoadjuvant chemotherapy
- to evaluate the overall tumor response to the neoadjuvant chemotherapy
An estimated of 8 to 21 patients will be enrolled in this study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
to establish an optimal dose of weekly cisplatin plus paclitaxel for 3 cyclesas neoadjuvant chemotherapy (NAC) for FIGO IB2 and bulky IIA, squamous cell cervical cancer, followed by radical hysterectomy and pelvic lymphadenectomy
18 months
Yes
HAO LIN, MD
Principal Investigator
Chang Gung Memorial Hospital, Kaohsiung
Taiwan: Department of Health
97-0365A3
NCT00823186
February 2009
January 2013
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