Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Nimotuzumab
* Drug: Irinotecan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nimotuzumab and Irinotecan<br>Nimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles | Drug: Nimotuzumab<br>* 200,400,600 or 800mg weekly until progression or AEs<br>Drug: Irinotecan<br>* 180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of grade 3/4 toxicity |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum tolerated |  | 3 months | 
| The complete response rate |  | 3 months | 
| The partial rate |  | 3 months | 
| The disease control rate |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nimotuzumab, colorectal cancer, chemotherapy