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Phase I Dose Escalation Study Of Weekly Paclitaxel and Cisplatin Followed by Radical Hysterectomy in FIGO IB2 and Bulky IIA Cervical Cancer


Phase 1
35 Years
70 Years
Open (Enrolling by invite only)
Female
Cervical Cancer

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Trial Information

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.


Inclusion Criteria:



women aged 35-70 years with all of the following criteria: untreated, histologically
confirmed squamous cell carcinoma of the uterine cervix FIGO stage IB2 or bulky IIA, with
tumor extension limited to within the upper one third of the vaginal wall. Bulky tumor is
defined as (a) a visible cervical tumor with the largest diameter >4 cm or (b) a cervix
expanded to > 4 cm as a result of tumor infiltration by pelvic examination and verified by
magnetic resonance image (MRI), 3-dimensional (D) computed tomography (CT), or 3-D
ultrasound study no suspicious lymph node metastasis as no enlarged lymph node or
extrapelvic spread of cancer detected by MRI, or negative cytologic or histologic study of
the suspicious node(s) (for those also participating PET-CT monitoring response trial,
only abnormal FDG uptake in pelvic node(s) without proven nodal or extrapelvic metastasis
are eligible)

Exclusion Criteria:

Histological or cytological documented pelvic lymph node or extrapelvic metastasis,
concurrent or history of malignant tumor(s) other than treated nonmelanoma skin cancer had
undergone surgical procedure other than cervical biopsy or had received cytotoxic
procedure including chemotherapy, radiotherapy or treatment with biologic response
modifier(s) for the cervical tumor participate in investigational treatment for the
cervical cancer history of allergic reaction to platinum or paclitaxel uncontrolled
intercurrent illness including, but not limited to, ongoing or active infection,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
psychiatric illness/social situations that would limit compliance with study requirements
pregnant or breast feeding women, a urinary pregnancy test must be performed on all
patients who are of child-bearing potential before entering the study and the result must
be negative

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Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

HAO LIN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chang Gung Memorial Hospital, Kaohsiung

Authority:

Taiwan: Department of Health

Study ID:

97-0365A3

NCT ID:

NCT00823186

Start Date:

February 2009

Completion Date:

January 2013

Related Keywords:

  • Cervical Cancer
  • cervical carcinoma
  • neoadjuvant chemotherapy
  • Uterine Cervical Neoplasms

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