Study of Nimotuzumab to Treat Colorectal Cancer

Advanced Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00972465
• Other study ID #: BT-CRC-T
• Status: Recruiting
• Phase: Phase 2
• First received: September 4, 2009
• Last updated: September 4, 2009
• Start date: June 2009
• Est. completion date: April 2010

Study information

• Verified date: September 2009
• Source: Peking University
• Contact: Shen Lin
• Phone: 86-01-88196561
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent form signed before performing any of the study's specific procedures.

• ECOG performance status 0-2.

• Age > 18,both genders.

• Metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer

• Disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment

• At least 1 measurable lesions ,( longest diameter= 1 cm by spiral computed tomography (CT) scan or MRI)

• Life expectancy more than 3 months.

• K-ras is wild type

• Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.

• Liver metastasis, lesions smaller than 50% of the liver; Lung metastasis, lesions smaller than 30% of the lung

• Haemoglobin=90g/L , granulocyte=1.5×109/L ,WBC =3×109/L, platelet count=100×109/L

• TBIL= 1.5 x ULN ,ALK= 2.5 x ULN or = 5ULN(Liver metastasis),AST and ALT= 2.5 x ULN or = 5ULN(Liver metastasis),Creatinine = 1.5 x ULN

• No brain metastasis

Exclusion Criteria:

• Previous radiotherapy at lesions within three months

• Other first line chemo-agents treatment except oxaliplatin ± fluorouracil

• Received other anti EGFR monoclonal antibody treatment

• Complete or incomplete intestinal obstruction

• Participation in other interventional clinical trials within 1 month

• Psychiatric disease affected cognitive ability, including brain metastasis

• Peripheral neuropathy lesion is more than I stage

• History of serious allergic or allergy

• Pregnant or breast-feeding women

• Patients with the history of Serious lung or hear disease

• Other malignant tumor

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Nimotuzumab and chemotherapy
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)

Locations

Country	Name	City	State
China	Peking University, School of Oncology, Beijing Cancer Hospital & Institute	Beijing
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	China People's Liberation Army (PLA)81 Hospital	Nanjing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.		within study period	Yes
Secondary	To determine the complete response rate, partial rate, disease response rate, disease control rate in the patients subject to treatment		3 months	No