Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

NCT ID: NCT02039791

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-08-31

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nimotuzumab plus chemoradiotherapy

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: BIOLOGICAL

200mg/w,weekly, 6 weeks

Carboplatin

Intervention Type: DRUG

AUC 6, d1，1 cycle/21d, 2 cycles

Paclitaxel

Intervention Type: DRUG

175 mg/m2, d1

1 cycle/21d, 2 cycles.

Interventions

Nimotuzumab

200mg/w,weekly, 6 weeks

Intervention Type: BIOLOGICAL

Carboplatin

AUC 6, d1，1 cycle/21d, 2 cycles

Intervention Type: DRUG

Paclitaxel

175 mg/m2, d1

1 cycle/21d, 2 cycles.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yaping Zhu

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai first people's hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

BT-IST-CC-072

Identifier Type: -

Identifier Source: org_study_id