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Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Nimotuzumab
Type: Biological
Name: Carboplatin
Type: Drug
Name: Paclitaxel
Type: Drug
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
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
Location
Shanghai first people's hospital
Shanghai, Shanghai, China
Status: Recruiting
Contact: yaping zhu - 13371989235
Start Date
January 2013
Completion Date
August 2016
Sponsors
Biotech Pharmaceutical Co., Ltd.
Source
Biotech Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page