Clinical trial NCT00972465: Study of Nimotuzumab to Treat Colorectal Cancer
Official title: Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Colorectal Cancer
Keywords: nimotuzumab colorectal cancer chemotherapy
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Biotech Pharmaceutical Co., Ltd.
First posted: 2009-09-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
timeFrame: within study period
Secondary outcomes:
measure: To determine the complete response rate, partial rate, disease response rate, disease control rate in the patients subject to treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Beijing
country: China
facility: Peking University, School of Oncology, Beijing Cancer Hospital & Institute
city: Nanjing
country: China
facility: China People's Liberation Army (PLA)81 Hospital
Study officials:
affiliation: Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
name: Shen Lin
role: PRINCIPAL_INVESTIGATOR
References: