Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02039791
• Other study ID #: BT-IST-CC-072
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 8, 2014
• Last updated: August 17, 2015
• Start date: January 2013
• Est. completion date: August 2016

Study information

• Verified date: August 2015
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Biological:
• Nimotuzumab
200mg/w,weekly, 6 weeks

Drug:
• Carboplatin
AUC 6, d1,1 cycle/21d, 2 cycles
• Paclitaxel
175 mg/m2, d1 1 cycle/21d, 2 cycles.

Locations

Country	Name	City	State
China	Shanghai first people's hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resection rate		the day right after surgery	No
Primary	Pathological response rate		the day right after surgery	No
Secondary	objective response rate(ORR)		The first seven weeks after the end of treatment	No
Secondary	Progression free survival progression-free survival (PFS)		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.	No