Dose-finding Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and Bulky IIA Cervical Cancer
Status:
Unknown status
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
This phase I study is designed to establish an optimal dose of paclitaxel, under a fixed
cisplatin dose at 40 mg/m2, delivered every week for three weeks, as neoadjuvant therapy
before radical hysterectomy in bulky (FIGO IB2 or FIGO IIA with primary tumor dimension > 4
cm) squamous cell cervical cancer. This study will be conducted at all branches of Chang Gung
Memorial Hospital.
The starting dose of paclitaxel is 50 mg/m2, and will be escalated by increments of 10 mg/m2
to a maximum dose of 80 mg/m2. The drugs will be administered sequentially (paclitaxel first,
followed by cisplatin) within one day every week for three cycles.
A cohort of 3 patients, who are assessable for toxicity, is treated at each dose level. Each
patient receives a fixed dose of paclitaxel and cisplatin, without modification. If none of
the first 3 patients experiences a dose limiting toxicity (DLT, see definition below this
paragraph), then escalation to the next dose level will proceed. If one patient develops a
DLT, the cohort will be expanded to 6 patients. If no more than 1 of these 6 patients
experiences a DLT, then escalation to the next dose level will proceed. The maximum tolerated
dose (MTD) is the highest dose level at which no more than 1 of 6 patients experience a DLT.
This dose level will be considered as the recommended dose for Phase II study. Although
efficacy evaluation is not the main purpose of this study, a response rate of 60%, evaluated
immediately before or at surgery, in all cases who have undergone 2 cycles of therapy is
preset as a requirement for further phase II study using this regimen.The primary goal of NAC
in cervical cancer is to improve the feasibility of surgical treatment, radical hysterectomy,
without delaying the scheduled surgery or increasing the surgical risk or morbidity.
Therefore, the definition of DLT for NAC is responded to this principle, in addition to the
standard dose-limiting toxicity for phase I study.