Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

• Sponsor: Biotech Pharmaceutical Co., Ltd. (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02039791
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 43
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Biological: Nimotuzumab; Drug: Carboplatin; Drug: Paclitaxel	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
• Study Start Date: Jan 1, 2013
• Anticipated Primary Completion Date: Jun 1, 2016
• Anticipated Study Completion Date: Aug 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. resection rate [the day right after surgery]

2. Pathological response rate [the day right after surgery]

Secondary Outcome Measures

1. objective response rate（ORR） [The first seven weeks after the end of treatment]

2. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai first people's hospital	Shanghai	Shanghai	China	200080

Sponsors and Collaborators

• Biotech Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: yaping Zhu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biotech Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02039791
• Other Study ID Numbers: BT-IST-CC-072
• First Posted: Jan 20, 2014
• Last Update Posted: Aug 19, 2015
• Last Verified: Aug 1, 2015

• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Paclitaxel; Carboplatin; Nimotuzumab

Study Results

No Results Posted as of Aug 19, 2015