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Dose-finding Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and Bulky IIA Cervical Cancer

NCT00823186 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2010-01-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Phyxol(Paclitaxel)

Paclitaxel is 5ß,20-Epoxyl-1,2α,4,7,β 10 β,13 α-hexahydroxytax-11-en-9-one 4,10 -diacetae 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisocerine

Sponsors & Collaborators

  • Sinphar Pharmaceutical Co., Ltd

    collaborator OTHER

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • HAO LIN, MD · Chang Gung Memorial Hospital, Kaohsiung

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-01-31
Completion
2013-01-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00823186 on ClinicalTrials.gov