Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer
• Intervention / Treatment: Biological: Nimotuzumab; Drug: Carboplatin; Drug: Paclitaxel

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nimotuzumab plus chemoradiotherapy	Biological: Nimotuzumab; 200mg/w,weekly, 6 weeks; Drug: Carboplatin; AUC 6, d1，1 cycle/21d, 2 cycles; Drug: Paclitaxel; 175 mg/m2, d1 1 cycle/21d, 2 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
resection rate	the day right after surgery
Pathological response rate	the day right after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
objective response rate（ORR）	The first seven weeks after the end of treatment
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.

Collaborators and Investigators

• Sponsor: Biotech Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: yaping Zhu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Estimate): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 17, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Carboplatin; Paclitaxel; Nimotuzumab
• Other Study ID Numbers: BT-IST-CC-072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No