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

Primary Purpose

Cervical Cancer

Status

Unknown status

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

Phyxol(Paclitaxel)

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical carcinoma, neoadjuvant chemotherapy

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Chang Gung Memorial Hospital
Chang Gung Memory Hpspital
Taipei Chang Gung Memory Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phyxol,cancer,intra vascular flow

Arm Description

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 lymphedectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00823186

First Posted

January 13, 2009

Last Updated

January 3, 2010

Sponsor

Chang Gung Memorial Hospital

Collaborators

Sinphar Pharmaceutical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00823186

Brief Title

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

Acronym

Chemothreapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

January 2012 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Chang Gung Memorial Hospital

Collaborators

Sinphar Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

cervical carcinoma, neoadjuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phyxol,cancer,intra vascular flow

Arm Type

Experimental

Arm Description

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 lymphedectomy

Intervention Type

Drug

Intervention Name(s)

Phyxol(Paclitaxel)

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

18 months

Secondary Outcome Measure Information:

Title

to evaluate the toxicity of the study regimen and its impact to the radical hysterectomy after neoadjuvant chemotherapy

Time Frame

36 months

Title

to evaluate the overall tumor response to the neoadjuvant chemotherapy

Time Frame

36 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

HAO LIN, MD

Organizational Affiliation

Chang Gung Memorial Hospital, Kaohsiung

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chang Gung Memorial Hospital

City

Tao Yuan

State/Province

Lin kou

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Chang Gung Memory Hpspital

City

Chia Yi

Country

Taiwan

Facility Name

Taipei Chang Gung Memory Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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