Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

NCT02039791 | Unknown Phase 2 DMC

• 1 other identifier: BT-IST-CC-072
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• resection rate

  the day right after surgery

• Pathological response rate

  the day right after surgery

Secondary Outcomes (2)

• 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.

Study Arms (1)

Nimotuzumab plus chemoradiotherapy

EXPERIMENTAL

Biological: Nimotuzumab; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Nimotuzumab BIOLOGICAL

200mg/w,weekly, 6 weeks

Nimotuzumab plus chemoradiotherapy

Carboplatin DRUG

AUC 6, d1，1 cycle/21d, 2 cycles

Nimotuzumab plus chemoradiotherapy

Paclitaxel DRUG

175 mg/m2, d1 1 cycle/21d, 2 cycles.

Nimotuzumab plus chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:18-70 years
• Histological confirmed Cervical squamous cell carcinoma
• FIGO Stage: IB2-IIIB
• 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.
• At least one lesions can be measured
• No previous therapy
• ECOG performance status 0-2
• Life expectancy of more than 6 months
• 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
• Without lung or heart disease
• Without active infection
• Signed informed consent and submit to the organization of research

You may not qualify if:

• Severe systemic or uncontrolled disease, unfit for chemotherapy
• Neuropathy caused by any reason
• Psychiatric disease
• Other malignant tumor
• Bilateral renal pelvis and ureter hydrocephalus who can't be alleviated by ureteral stent or percutaneous nephrostomy, Abnormal serum creatinine level
• Infection and severe systemic disease
• Received other anti EGFR monoclonal antibody treatment
• Participation in other interventional clinical trials
• Allergic constitution or history of drug allergy
• Pregnant or breast-feeding or refused to take contraceptive method
• Poor compliance

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai first people's hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

nimotuzumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• yaping Zhu

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

CN (1)