Phase IIa 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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Nimotuzumab; Drug: Irinotecan

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100036
    • Peking University, School of Oncology, Beijing Cancer Hospital & Institute
  • Jiangsu
    • Nanjing, Jiangsu, China
      • China People's Liberation Army (PLA)81 Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biotech Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Lin Shen, Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: colorectal cancer; chemotherapy; nimotuzumab
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Topoisomerase I Inhibitors; Irinotecan; Nimotuzumab
• Other Study ID Numbers: BT-CRC-T