Study of Cetuximab to Treat KRAS Wild Type Metastatic Colorectal Cancer (CRC009)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Shanghai Biomabs Pharmaceuticals Co Ltd
Information provided by (Responsible Party):
Shanghai Zhangjiang Biotechnology Limited Company
ClinicalTrials.gov Identifier:
NCT01550055
First received: March 7, 2012
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

The primary purpose of this study is to evaluate the clinical response and safety of cetuximab plus irinotecan synchronously/subsequently in patients with KRAS wild-type metastatic colorectal cancer


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Cetuximab plus Irinotecan Synchronously
Drug: Irinotecan and Cetuximab Subsequently
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II/III Trial of Cetuximab Plus Irinotecan Synchronously/Subsequently in Patients With KRAS Wild-type Metastatic Colorectal Cancer: an Randomized, Open-label, Multicenter, Prospective Study

Resource links provided by NLM:


Further study details as provided by Shanghai Zhangjiang Biotechnology Limited Company:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Time to progression, assessed up to two years ] [ Designated as safety issue: No ]
    Tumor response was evaluated every 6 weeks and confirmed at least 4 weeks later


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: Time to progression, assessed up to two years ] [ Designated as safety issue: No ]
    The study was designed to evaluate the PFS as second end point, progression-free survival is defined as the period from date of randomization to date of disease progression


Enrollment: 512
Study Start Date: March 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab plus Irinotecan Synchronously Drug: Cetuximab plus Irinotecan Synchronously
Combined with irinotecan 180 mg/m2 every 2 weeks, Cetuximab 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression
Other Names:
  • CMAB009 for cetuximab
  • YiMaiLin for irinotecan
Active Comparator: Irinotecan and Cetuximab Subsequently Drug: Irinotecan and Cetuximab Subsequently
First, irinotecan 180 mg/m2 every 2 weeks till PD occured, discontinue it; then, cetuximab 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression.
Other Names:
  • CMAB009 for cetuximab
  • YiMaiLin for irinotecan

Detailed Description:

CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is expressed by Chinese hamster ovary cells. It is a biosimilar of cetuximab (C225, Erbitux®) and it is developed by Shanghai Zhangjiang Biotechnology Limited Company and produced by Biomabs. Phase I study results suggest that CMAB009 showed well-tolerated safety profile and primary efficacy. This multicenter, open-label study was to determine whether adding cetuximab (CMAB009) to irinotecan increased the response rate and prolongs survival in patients with KRAS wild-type metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed metastatic colorectal adenocarcinoma
  • KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;
  • has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre by physical examination or other iconography
  • ECOG performance status 0 to 1
  • Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve

Exclusion Criteria:

  • Previous irinotecan or anti-EGFR therapies
  • hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter
  • liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not
  • Renal function: serum creatinine, more than 1.5 times the upper limit of normal
  • Patients with symptomatic central nervous system metastases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550055

Sponsors and Collaborators
Shanghai Zhangjiang Biotechnology Limited Company
Shanghai Biomabs Pharmaceuticals Co Ltd
Investigators
Study Chair: Yuankai Shi, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Principal Investigator: B C Mei Peking Union Medical College Hospital
Principal Investigator: B Li Chinese PLA Affiliated Central Hospital
Principal Investigator: X J Ming Affiliated Hospital of Chinese PLA Military Academy of Medical Science
Principal Investigator: B Yi TianJin Medical University Affiliated Cancer Hospital
Principal Investigator: Y Qiang NanKai University Affiliated Hospital
Principal Investigator: L Wei HeBei Medical University Fouth Hospital
Principal Investigator: L Y Peng Chinese Medical University First Affiliated Hospital
Principal Investigator: W B Cheng Jinan Military Central Hospital
Principal Investigator: W Z Hai Shandong Provincal Cancer Hospital
Principal Investigator: Y S Ying Tongji Medical College of Huazhong University of Science and Technology
Principal Investigator: L Yi Hunan Provincal Cancer Hospital
Principal Investigator: C Y Gui Fujian Provincal Cancer Hospital
Principal Investigator: W L Wei Shanghai Jiaotong University Affiliated First People's Hospital
Principal Investigator: Z Jun Shanghai Jiaotong University Affiliated Ruijin Hospital
Principal Investigator: H C Hong Central South University
Principal Investigator: OY Xuenong Fuzhou Central Hospital of Nanjing Military Command
Principal Investigator: L Jin Fudan University Affiliated Cancer Hospital
Principal Investigator: Z Y Ping Zhejiang Provincal Cancer Hospital
Principal Investigator: H X Hua Guangxi Medical University Affiliated Cancer Hospital
Principal Investigator: L R Cheng Nanfang Medical University Affiliated Nanfang Hospital
Principal Investigator: L Y Hong Zhongshan University Affliated Cancer Hospital
Principal Investigator: T Min Suzhou University Affiliated First Hospital
Principal Investigator: Z Z Xiang Suzhou University Affiliated Second Hospital
Principal Investigator: C Ying Jilin Provincal Cancer Hospital
Principal Investigator: F J Feng Jiangsu Provincal Cancer Hospital
Principal Investigator: Q S Qui Chinese PLA Affiliated 81 Hospital
Principal Investigator: J Bin Shanghai Jiaotong University Affiliated Third People's Hospital
Principal Investigator: Z R Sheng Bengbu Medical College Affiliated Hospital
Principal Investigator: M G Xin Nantong Medical College Affiliated Hospital
Principal Investigator: S G Ping Anhui Medical University Affiliated First Hospital
Principal Investigator: D W Chao The Fourth Military University Affiliated First Hospital
Principal Investigator: L H Jie The Third Military University Affiliated First Hospital
Principal Investigator: X Ying Chongqing Cancer Hospital
Principal Investigator: F Min Chongqing First People's Hospital
Principal Investigator: B Feng Sichuan University Huaxi Hospital
Principal Investigator: W D Lin Sichuan Provincal People's Hospital
Principal Investigator: Z W Hua Gansu Provincal Cancer Hospital
Principal Investigator: C Hong Kunming Central Hospital of Chengdu Military Command
  More Information

No publications provided

Responsible Party: Shanghai Zhangjiang Biotechnology Limited Company
ClinicalTrials.gov Identifier: NCT01550055     History of Changes
Other Study ID Numbers: CMAB009mCRCⅡ/Ⅲ, CMAB009
Study First Received: March 7, 2012
Last Updated: October 24, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Zhangjiang Biotechnology Limited Company:
KRAS wild-type
Metastatic Colorectal Cancer
CMAB009 Plus Irinotecan
Phase II/III

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Irinotecan
Camptothecin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014