Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotech Pharmaceutical Co., Ltd.
• Treatments: Irinotecan; Nimotuzumab

Criteria

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