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Trial Title:
Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
NCT ID:
NCT02039791
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Carboplatin
Nimotuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Nimotuzumab
Description:
200mg/w,weekly, 6 weeks
Arm group label:
Nimotuzumab plus chemoradiotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
AUC 6, d1，1 cycle/21d, 2 cycles
Arm group label:
Nimotuzumab plus chemoradiotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
175 mg/m2, d1
1 cycle/21d, 2 cycles.
Arm group label:
Nimotuzumab plus chemoradiotherapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age:18-70 years
2. Histological confirmed Cervical squamous cell carcinoma
3. FIGO Stage: IB2-IIIB
4. 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.
5. At least one lesions can be measured
6. No previous therapy
7. ECOG performance status 0-2
8. Life expectancy of more than 6 months
9. 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
10. Without lung or heart disease
11. Without active infection
12. Signed informed consent and submit to the organization of research
Exclusion Criteria:
1. Severe systemic or uncontrolled disease, unfit for chemotherapy
2. Neuropathy caused by any reason
3. Psychiatric disease
4. Other malignant tumor
5. Bilateral renal pelvis and ureter hydrocephalus who can't be alleviated by ureteral
stent or percutaneous nephrostomy, Abnormal serum creatinine level
6. Infection and severe systemic disease
7. Received other anti EGFR monoclonal antibody treatment
8. Participation in other interventional clinical trials
9. Allergic constitution or history of drug allergy
10. Pregnant or breast-feeding or refused to take contraceptive method
11. Poor compliance
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai first people's hospital
Address:
City:
Shanghai
Zip:
200080
Country:
China
Start date:
January 2013
Completion date:
August 2016
Lead sponsor:
Agency:
Biotech Pharmaceutical Co., Ltd.
Agency class:
Other
Source:
Biotech Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02039791
