Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Nimotuzumab

Antineoplastic Agents, Immunological

Experimental: Nimotuzumab and Irinotecan

the chemotherapy treatment: Irinotecan (180 mg/m2/time, 1 time/14 days, until disease progression)

the nimotuzumab treatment: 3 levels (200 mg/w, 400 mg/w, 600 mg/w, weekly, until disease progression)

Nimotuzumab and chemotherapy

Shen Lin

ruihua Xu, M.D., Ph.D.

Jun Zhou, MD. PhD

Shukui Qin

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.

Nimotuzumab and Irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment.Irinotecan will be administered once every 14 days,the dosage is 180mg/m2; Nimotuzumab treatment be divided 3 levels:200mg/w,400mg/w,600mg/w,weekly.The patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks,when the total result is the CR or PR, the result of the 6th and the 12th week should be compared.

Study of Nimotuzumab to Treat Colorectal Cancer

Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras

Biotech Pharmaceutical Co., Ltd.

Peking University

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Docetaxel

Cisplatin

The chemotherapy treament：docetaxel( 75mg/m2/d,every21days,for4\~6cycles) and cisplatin(total dose 75mg/m2 on day 2,3,4,every21days,for4\~6cycles).

the nimotuzumab treatment:3 levels (200mg/w,400mg/w,600mg/w,weekly,for12\~18 weeks).

Yuankai Shi, Professor

Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).

Altered expression or constitutive activation of the epidermal growth factor receptor (EGFR/HER1/erbB1) commonly occurs in primary NSCLC, and is often a critical factor in progressive growth and resistance to normal mechanisms of cell death. Epidermal growth factor receptor expression in lung cancer has been correlated with tumor aggressiveness. Clinical trials already suggest that EGFR targeted therapy may improve the antitumor activity of chemotherapy for treatment of lung carcinoma. Monoclonal antibodies specific to EGFR can be combined safely and effectively with chemotherapy. Nimotuzumab (hR3) is a humanized monoclonal antibody (mAb) that binds to the EGFR. In preclinical studies the antibody has shown potent antitumor activity. A previous phase II study in children with high grade brain tumors showed activity of Nimotuzumab as a monotherapeutic agent, even in prognostic very unfavourable diffuse, intrinsic pontine glioma. No drug related side effects were reported. Nimotuzumab (hR3) in combination with radiotherapy for treatment of locally advanced squamous cell carcinomas of the head and neck resulted in high rates of antitumor response, and was accompanied by a favourable safety profile.

This is a dose-escalation study of Nimotuzumab. Nimotuzumab in combination with chemotherapy will be administered to the patients with advanced NSCLC. The patients' blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks. When the total result is the CR or PR, the results of the 6th, 12th, 18th and the 22th week should be compared.

Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer

Phase 1 Study of Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Fluorouracil

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Chemotherapy

:Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)

Nimotuzumab treatment:(200mg/w,18weeks );

Chemotherapy treatment: Docetaxel(75mg/m²,1 time/21d, 6times，);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times),Nimotuzumab treatment:(200mg/w,18weeks ).

Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)

Chemotherapy

Nimotuzumab treatment:(200mg/w,18weeks );

Chemotherapy treatment:(Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)Nimotuzumab treatment:(200mg/w,18weeks );

Nimotuzumab and Chemotherapy

Wei Guo, MD, PhD, DDS

Nimotuzumab (hR3) is an humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). In phase II clinical trials a combination of Nimotuzumab with chemotherapy or radiation therapy achieved satisfactory therapeutic outcomes in patients with advanced squamous cell carcinoma of head and neck, or glioblastoma. We therefore postulated that Nimotuzumab in combination with conventional definitive chemotherapy might improve the rate of disease control (RDC), progression-free survival (PFS),and overall survival in patients with recurrent and/or metastatic SCCHN , which is a poor-prognosis patient population for whom there is currently no standard treatment approach, we designed this trial to test this hypothesis.

Eligible patients were randomly assigned by using permutated blocks designed11 for each site to receive either Nimotuzumab combined with docetaxel-cisplatin-fluorouracil regimen (Arm A) or docetaxel-cisplatin-fluorouracil alone regimen (Arm B). Combination arm chemotherapy was as conducted as follows. Since day 1, Nimotuzumab (200 mg, given as a 2-hour intravenous infusion before chemotherapy, Biotech Pharmaceutical Inc., Beijing, China) was administrated 1 h before chemotherapy once a week for two successive courses, followed by docetaxel (at a dose of 75 mg per square meter of body-surface area) was administered as a 1-hour intravenous infusion, followed by intravenous cisplatin (75 mg per square meter), administered during a period of 0.5 to 3 hours. After completion of the cisplatin infusion, fluorouracil (1000 mg per square meter per day) was administered as a continuous 24-hour infusion for 4 days. Patients in arm A received docetaxel-cisplatin-fluorouracil only.One treatment cycle comprised a period of 3 weeks (21 days). Patients received six cycles in both treatment arms, unless disease progression or unacceptable toxicity was observed. Patients in the experimental group who had at least stable disease could choose to continue maintenance Nimotuzumab every week until disease progression, intolerable toxicity, or study withdrawal.

Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma

Phase 2 Study of Nimotuzumab in Combination With TPF for Head and Neck Squamous Cell Carcinoma

Sun Yat-sen University

Wei Guo

Guo Wei, Shanghai 9th People's Hospital.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Nimotuzumab to Treat Colorectal Cancer	NCT00972465	Advanced Colore...	Nimotuzumab and...	18 Years -	Peking University
Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer	NCT00985998	Non-small Cell ...	Nimotuzumab and...	18 Years - 65 Years	Biotech Pharmaceutical Co., Ltd.
Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma	NCT01425736	Head and Neck S...	Chemotherapy Nimotuzumab and...	18 Years - 75 Years	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma	NCT01425736	Head and Neck S...	Chemotherapy Nimotuzumab and...	18 Years - 75 Years	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Spots Global Cancer Trial Database for nimotuzumab and chemotherapy