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Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras

Phase 2
18 Years
Open (Enrolling)
Advanced Colorectal Cancer

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Trial Information

Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras

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.

Inclusion Criteria:

- Informed consent form signed before performing any of the study's specific

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.

Outcome Time Frame:

within study period

Safety Issue:


Principal Investigator

Shen Lin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute


China: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

April 2010

Related Keywords:

  • Advanced Colorectal Cancer
  • nimotuzumab colorectal cancer chemotherapy
  • Colorectal Neoplasms