Clinical trial NCT02432365: Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy
Official title: Phase II Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and IIA2 Cervical Cancer Followed by Radical Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: Paclitaxel
Cisplatin
Cervical cancer
Radical hysterectomy
Neoadjuvant
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Asian Gynecologic Oncology Group
name: Taiwanese Gynecologic Oncology Group
First posted: 2015-05-04
Enrollment: 64
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survivial
timeFrame: January 31, 2023 (5 years)
Secondary outcomes:
measure: Safety (If > 6 significant G3/4 AEs occur)
timeFrame: January 31, 2023 (up to 5 years)
measure: Response rate (Pathological response)
timeFrame: Post-operative 1 month
measure: Postoperative RT/CRT rate
timeFrame: Post-operative 6 months
measure: Quality-of-life
timeFrame: at completion of neoadjuvant chemotherapy
measure: Progression-free survival
timeFrame: January 31, 2023 (up to 5 years)
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Department of Obstetrics and Gynecology, Chung Shan Medical University Hospital
city: Taipei
country: Taiwan
facility: Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Linkou Medical Center
Study officials:
affiliation: Gynecologic oncology
name: Huei-Jean Huang, M.D
role: PRINCIPAL_INVESTIGATOR
References: