- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00972465
Study of Nimotuzumab to Treat Colorectal Cancer
September 4, 2009 updated by: Peking University
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
Unknown
Conditions
Intervention / Treatment
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 (Anticipated)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shen Lin
- Phone Number: 86-01-88196561
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking University, School of Oncology, Beijing Cancer Hospital & Institute
-
Contact:
- Jun Zhou, MD. PhD
- Phone Number: 88196088
- Email: joelbmu@126.com
-
Nanjing, China
- Not yet recruiting
- China People's Liberation Army (PLA)81 Hospital
-
Contact:
- Shukui Qin
- Phone Number: 13905158713
- Email: qinshukui@csco.org.cn
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Not yet recruiting
- Sun Yat-sen University Cancer Center
-
Contact:
- ruihua Xu, M.D., Ph.D.
- Phone Number: 13922206676
- Email: xurh@mail.sysu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
Time Frame: within study period
|
within study period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the complete response rate, partial rate, disease response rate, disease control rate in the patients subject to treatment
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shen Lin, Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Anticipated)
December 1, 2009
Study Completion (Anticipated)
April 1, 2010
Study Registration Dates
First Submitted
September 4, 2009
First Submitted That Met QC Criteria
September 4, 2009
First Posted (Estimate)
September 7, 2009
Study Record Updates
Last Update Posted (Estimate)
September 7, 2009
Last Update Submitted That Met QC Criteria
September 4, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BT-CRC-T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Colorectal Cancer
-
Zhejiang UniversityRecruitingAdvanced Colorectal Cancer | Advanced Hepatocellular Carcinoma | Advanced Gastric Cancer | Advanced Pancreatic CancerChina
-
Array Biopharma, now a wholly owned subsidiary...CompletedMetastatic Colorectal Cancer | Advanced Solid Tumors | Advanced or Metastatic Biliary CancerUnited States
-
University Health Network, TorontoRecruitingAdvanced Breast Cancer | Advanced Colorectal Cancer | Cancer RehabilitationCanada
-
Haihe Biopharma Co., Ltd.UnknownAdvanced Solid Tumor | Advanced/Metastatic Colorectal CancerChina
-
University of ChicagoVerastem, Inc.RecruitingColorectal Cancer | Colorectal Cancer Metastatic | Colorectal Adenocarcinoma | Advanced Colorectal Carcinoma | Advanced Colorectal AdenocarcinomaUnited States
-
Sun Yat-sen UniversityRecruitingDMMR Colorectal Cancer | MSI-H Colorectal Cancer | Locally Advanced Colorectal CancerChina
-
AVEO Pharmaceuticals, Inc.CompletedAdvanced Solid Tumors | Locally Advanced or Metastatic Breast or Colorectal CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingMetastatic Colorectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Metastatic Microsatellite Stable Colorectal Carcinoma | Advanced Microsatellite Stable Colorectal Carcinoma | Advanced Colorectal AdenocarcinomaUnited States
-
Holy Stone Healthcare Co., LtdCompletedAdvanced or Metastatic Solid Tumors | Advanced or Metastatic Colorectal Cancer (mCRC)United States
-
Mirati Therapeutics Inc.Active, not recruitingMetastatic Colorectal Cancer | Advanced Colorectal CancerUnited States, Denmark, Finland, Italy, Spain, Belgium, Romania, Taiwan, Thailand, France, Germany, Korea, Republic of, China, Malaysia, Hong Kong, Australia, Austria, Puerto Rico, Singapore, Canada, Portugal, Poland, Greece, United Kingdom and more
Clinical Trials on Nimotuzumab and chemotherapy
-
Biotech Pharmaceutical Co., Ltd.WithdrawnNon-small Cell Lung CancerChina
-
Fudan UniversityThe First Affiliated Hospital of Xiamen University; Fujian Province Tumor HospitalCompletedNasopharyngeal CarcinomaChina
-
The First Affiliated Hospital of Soochow UniversityBiotech Pharmaceutical Co., Ltd.; Cinda Biopharmaceutical (Suzhou) Co., Ltd.Not yet recruitingRecurrent/Metastatic Head and Neck Squamous Cell Carcinoma
-
Fudan UniversityRenJi Hospital; Shanghai Chest Hospital; Shanghai General Hospital, Shanghai... and other collaboratorsUnknown
-
Biotech Pharmaceutical Co., Ltd.Not yet recruitingGastric or Esophagogastric Junction Adenocarcinoma
-
Wei GuoSun Yat-sen UniversityCompletedHead and Neck Squamous Cell CarcinomaChina
-
The First Affiliated Hospital with Nanjing Medical...Enrolling by invitation
-
Fudan UniversityRecruiting
-
Peking UniversityBiotech Pharmaceutical Co., Ltd.Unknown
-
Cancer Institute and Hospital, Chinese Academy...UnknownGastric Cancer | Concurrent ChemoradiotherapyChina