Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy

Cervical Cancer Clinical Trial

Official title:

Phase II Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02432365
• Other study ID #: AGOG14-001/TGOG1008
• Secondary ID: IRB103-4781A3
• Status: Recruiting
• Phase: Phase 2
• First received: February 10, 2015
• Last updated: October 27, 2017
• Start date: February 2015
• Est. completion date: December 2023

Study information

• Verified date: October 2017
• Source: Chang Gung Memorial Hospital
• Contact: Huei-Jean Huang, M.D
• Phone: 03-3281200
• Email: hjhuang[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose was to establish a quick (7-day) cycle schedule of paclitaxel (60 mg/m2) combining with cisplatin (40 mg/m2) NAC regimen could be tolerated without interfering the following surgical treatment and a favorable overall survival rate for stages IB2 and IIA2 cervical squamous cell carcinoma (SCC).

Description:

This is a multi-center, open-label, Simon's 2-stage, phase II study of paclitaxel and cisplatin as neoadjuvant therapy in patients with FIGO IB2 or IIA2, squamous cell cervical carcinoma of the uterine cervix.

Primary Objectives:

• Overall survival

Secondary Objectives:

• Safety

• Progression-free survival

• Response rate

• Postoperative RT/CRT rate

• To assess Quality-of-life

An estimate of 64 evaluable patients will be enrolled in this phase II investigation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Women with previously untreated, histologically confirmed squamous cell carcinoma of the uterine cervix

2. HPV16-positive aged 35-70 years or HPV16-negative age <55 years

3. FIGO stage IB2 or bulky IIA, with tumor extending to the vagina within the upper one third of the vaginal wall. Bulky tumor is defined as

1. 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

2. verified by magnetic resonance image (MRI) or 3-dimensional (D) computed tomography (CT)

4. no suspicious extrapelvic metastasis detected by MRI or 3-D CT

5. adequate marrow, liver and renal functions :hemoglobin level >= 10 g/dL, WBC count >= 3,000/mm3 or absolute neutrophil count >= 1,500/mm3, platelet count >= 100,000/mm3, serum transaminase (AST, ALT) levels <= 60 IU/mL, total serum bilirubin within normal range, serum creatinine level <= 1.5 mg/dL, and blood urea nitrogen level <=20 mg/dL

6. adequate cardiopulmonary function that tolerates the administration of study regimen and radical hysterectomy

7. Eastern Cooperative Oncology Group performance status of 0 to 1

8. had written informed consent to participate in the study

9. Appropriate organ and marrow function :

leukocytes >=3,000/µL absolute neutrophil count >= 1,500/µL platelets >= 100,000/µL (not platelet transfusion dependent) hemoglobin >= 10 g/dL total bilirubin within normal range AST/ALT <= 2.5 X upper limit of normal range (ULN) BUN <= 20 mg/dL serum creatinine <=1.5 mg/dL or clearance > 60 mL/min

10. a negative urinary pregnancy test in a patient with child-bearing potential

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

1. adenocarcinoma , adenosquamous carcinoma, or small cell carcinoma

2. concurrent or history of malignant tumor(s) other than treated nonmelanoma skin cancer

3. had received surgical procedure other than cervical biopsy or cytotoxic procedure including chemotherapy, radiotherapy or therapy with biologic response modifier(s) for the cervical tumor

4. enlarged pelvic lymph node with positive aspiration cytologic or histologic study

5. participate in investigational treatment or another clinical trial for cervical cancer

6. history of allergic reaction to platinum or paclitaxel

7. 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

8. pregnant or breast feeding women

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• paclitaxel
7-day cycle schedule of paclitaxel (60 mg/m2)
• cisplatin
7-day cycle schedule of cisplatin (40 mg/m2)

Procedure:
• Radical hysterectomy and bilateral pelvic lymphadenectomy
2 weeks after last course of neoadjuvant chemotherapy

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital	Chiayi City
Taiwan	Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Department of Obstetrics and Gynecology, Chung Shan Medical University Hospital	Taichung
Taiwan	Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital	Taipei
Taiwan	Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Linkou Medical Center	Taoyuan

Sponsors (3)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Asian Gynecologic Oncology Group, Taiwanese Gynecologic Oncology Group

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survivial	The primary objective is to determinate the difference in 5-year survival rate of subjects with NAC+RH-PLND compared with standard CCRT. Based on the pilot research, the 5-year survival rate of NAC+RH-PLND is expected to be around 87.5%. Thus, a sample size of 64 subjects in NAC+RH-PLND group is required for correctly detecting a 12.5% difference between 5-year OS rate of NAC+RH-PLND group and a reference value 75% of standard CCRT in order to achieving an 80% power at a significance level 0.05.	January 31, 2023 (5 years)
Secondary	Safety (If > 6 significant G3/4 AEs occur)	If > 6 significant G3/4 AEs occur	January 31, 2023 (up to 5 years)
Secondary	Response rate (Pathological response)	Pathological response will be calculated	Post-operative 1 month
Secondary	Postoperative RT/CRT rate	Postoperative RT/CCRT will be given to defined high-risk group	Post-operative 6 months
Secondary	Quality-of-life	using EORTC QLQ-C30, EORTC-QLQ-CX24	at completion of neoadjuvant chemotherapy
Secondary	Progression-free survival	PFS will be evaluated using Kaplan-Meier method	January 31, 2023 (up to 5 years)

External Links

•   Drug Information available for: Cisplatin
•   Drug Information available for: Paclitaxel
•   MedlinePlus related topics
•   U.S. FDA Resources