Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Carboplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- Age:18-70 years
- Histological confirmed Cervical squamous cell carcinoma
- FIGO Stage: IB2-IIIB
- Tumor lesions and stages are confirmed by the internal medicine, obstetrics and gynecology inspection, including a pelvic exam and abdominal and pelvic CT,.if necessary, laparoscopy, cystoscopy and pelvic MRI examination will be taken.
- At least one lesions can be measured
- No previous therapy
- ECOG performance status 0-2
- Life expectancy of more than 6 months
- Normal hematology:Haemoglobin≥90g/L,white blood cell(WBC)≥4×109/L Absolute neutrophil count≥1.5×109/L,platelet count≥100×109/L, normal renal function: serum creatinine<1.5mg/dl or creatinine clearance rate>60ml/min;normal liver function:TBIL≤1.5 ULN, AST and ALT≤1.5 ULN
- Without lung or heart disease
- Without active infection
- Signed informed consent and submit to the organization of research
Exclusion Criteria:
- Severe systemic or uncontrolled disease, unfit for chemotherapy
- Neuropathy caused by any reason
- Psychiatric disease
- Other malignant tumor
- Bilateral renal pelvis and ureter hydrocephalus who can't be alleviated by ureteral stent or percutaneous nephrostomy, Abnormal serum creatinine level
- Infection and severe systemic disease
- Received other anti EGFR monoclonal antibody treatment
- Participation in other interventional clinical trials
- Allergic constitution or history of drug allergy
- Pregnant or breast-feeding or refused to take contraceptive method
- Poor compliance
Sites / Locations
- Shanghai first people's hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nimotuzumab plus chemoradiotherapy
Arm Description
Outcomes
Primary Outcome Measures
resection rate
Pathological response rate
Secondary Outcome Measures
objective response rate(ORR)
Progression free survival progression-free survival (PFS)
Full Information
NCT ID
NCT02039791
First Posted
January 8, 2014
Last Updated
August 17, 2015
Sponsor
Biotech Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02039791
Brief Title
Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
Official Title
Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotech Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phaseⅡtrial is designed to assess the resection rate and pathological complete response of nimotuzumab plus carboplatin and paclitaxel in patients with cervical cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nimotuzumab plus chemoradiotherapy
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Nimotuzumab
Intervention Description
200mg/w,weekly, 6 weeks
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
AUC 6, d1,1 cycle/21d, 2 cycles
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
175 mg/m2, d1
1 cycle/21d, 2 cycles.
Primary Outcome Measure Information:
Title
resection rate
Time Frame
the day right after surgery
Title
Pathological response rate
Time Frame
the day right after surgery
Secondary Outcome Measure Information:
Title
objective response rate(ORR)
Time Frame
The first seven weeks after the end of treatment
Title
Progression free survival progression-free survival (PFS)
Time Frame
Follow-up is for three consecutive years after surgery. Once every three months in the first year, and then once every six months in the second and third year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age:18-70 years
Histological confirmed Cervical squamous cell carcinoma
FIGO Stage: IB2-IIIB
Tumor lesions and stages are confirmed by the internal medicine, obstetrics and gynecology inspection, including a pelvic exam and abdominal and pelvic CT,.if necessary, laparoscopy, cystoscopy and pelvic MRI examination will be taken.
At least one lesions can be measured
No previous therapy
ECOG performance status 0-2
Life expectancy of more than 6 months
Normal hematology:Haemoglobin≥90g/L,white blood cell(WBC)≥4×109/L Absolute neutrophil count≥1.5×109/L,platelet count≥100×109/L, normal renal function: serum creatinine<1.5mg/dl or creatinine clearance rate>60ml/min;normal liver function:TBIL≤1.5 ULN, AST and ALT≤1.5 ULN
Without lung or heart disease
Without active infection
Signed informed consent and submit to the organization of research
Exclusion Criteria:
Severe systemic or uncontrolled disease, unfit for chemotherapy
Neuropathy caused by any reason
Psychiatric disease
Other malignant tumor
Bilateral renal pelvis and ureter hydrocephalus who can't be alleviated by ureteral stent or percutaneous nephrostomy, Abnormal serum creatinine level
Infection and severe systemic disease
Received other anti EGFR monoclonal antibody treatment
Participation in other interventional clinical trials
Allergic constitution or history of drug allergy
Pregnant or breast-feeding or refused to take contraceptive method
Poor compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yaping Zhu
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai first people's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
We'll reach out to this number within 24 hrs