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Study of Nimotuzumab to Treat Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00972465
Recruitment Status : Unknown
Verified September 2009 by Peking University.
Recruitment status was:  Recruiting
First Posted : September 7, 2009
Last Update Posted : September 7, 2009
Sponsor:
Collaborator:
Biotech Pharmaceutical Co., Ltd.
Information provided by:
Peking University

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Colorectal Cancer Drug: Nimotuzumab and chemotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras
Study Start Date : June 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : April 2010

Intervention Details:
  • 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)

    Other Name: Nimotuzumab


Primary Outcome Measures :
  1. Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated. [ Time Frame: within study period ]

Secondary Outcome Measures :
  1. To determine the complete response rate, partial rate, disease response rate, disease control rate in the patients subject to treatment [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972465


Contacts
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Contact: Shen Lin 86-01-88196561

Locations
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China, Guangdong
Sun Yat-Sen University Cancer Center Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: ruihua Xu, M.D., Ph.D.    13922206676    xurh@mail.sysu.edu.cn   
China
Peking University, School of Oncology, Beijing Cancer Hospital & Institute Recruiting
Beijing, China
Contact: Jun Zhou, MD. PhD    88196088    joelbmu@126.com   
China People's Liberation Army (PLA)81 Hospital Not yet recruiting
Nanjing, China
Contact: Shukui Qin    13905158713    qinshukui@csco.org.cn   
Sponsors and Collaborators
Peking University
Biotech Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Shen Lin Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
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Responsible Party: Shen Lin, Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
ClinicalTrials.gov Identifier: NCT00972465    
Other Study ID Numbers: BT-CRC-T
First Posted: September 7, 2009    Key Record Dates
Last Update Posted: September 7, 2009
Last Verified: September 2009
Keywords provided by Peking University:
nimotuzumab colorectal cancer chemotherapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nimotuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents