Status:
TERMINATED
Nimotuzumab Plus Docetaxel in Chemotherapy-Refractory/Resistant Patients With Advanced Non-Small-Cell Lung Cancer
Lead Sponsor:
Biotech Pharmaceutical Co., Ltd.
Conditions:
Advanced Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Nimotuzumab is a humanized monoclonal anti-body targeting the epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzuma...
Detailed Description
Nimotuzumab and Docetaxel will be administered to the patient until disease progression or unacceptable toxicity had occurred.Docetaxel was administered every 3 weeks 75mg/m2; Nimotuzumab treatment at...
Eligibility Criteria
Inclusion
- Histological/cytological confirmed Non-small cell lung cancer
- EGFR expression is positive (Immunohistochemistry)
- Locally advanced or advanced NSCLC patients(Stage IIIb \\ IV)
- Patients must have had progressive disease after only one prior chemotherapy regimen.This regimen must have been platinum-based.(For the patients who received new adjuvant chemotherapy or adjuvant chemotherapy, only disease free survival within 9 months will be eligible to enrollment).
- The last dose of chemotherapy must be finished at least 3 weeks before the study, the acute toxicity of chemotherapy must be recovery.
- The patients previously received radiotherapy could be recruited. (bone marrow influenced by radiotherapy should be less than 25% of the total quantity of general bone marrow ,and the patients didn't receive the whole pelvis radiation, last radiotherapy must be finished at least 4 weeks before the enrollment. )
- Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging, or computed tomography in at least one dimension with longest diameter to be recorded as ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT.
- ECOG performance status 0-2.
- Life expectancy ≥ 12 weeks.
- Adequate organic function must be according with the following:
- Barrow: Absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L, Haemoglobin ≥ 90g/L;
- Liver function: BIL ≤ 1.5 x ULN, ALP, AST and ALT≤ 3x ULN or ≤ 5 ULN (Liver metastasis);
- Renal function: Ccr ≥ 45ml/min;
- No history of clinically significant or uncontrolled cardiac disease, normal electrocardiogram(ECG).
- Use of an effective contraceptive method for patients of both genders during study and after the end of 3 months, female subjects must be non breast feeding period and serum or urine pregnancy test should be negative.
- Signed informed consent and submit to the organization of research
Exclusion
- Brain metastasis and with symptom
- Previously treatment regimen including:Docetaxel, anti EGFR monoclonal antibody,anti-angiogenesis targeted medicine,small molecule tyrosine kinase inhibitor(TKIs)
- Receiving other anti-cancer medicine treatment during the study
- Uncontrolled pleural effusion、seroperitoneum、pericardial effusion
- Serious illness or other malignancies diagnosed within the past five years.
- Patients with any serious active infection
- The second primary malignant tumor
- Serious accompanying disease would influenced the study (such as cardiac disease,Diabetes mellitus etc)
- Contraindication of hormone therapy
- Previous definable peripheral neuropathy and with symptom
- Do not sign informed consent form
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00983047
Start Date
August 1 2009
End Date
August 1 2015
Last Update
August 27 2015
Active Locations (1)
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1
Peking University School of Oncology, Beijing Institute for Cancer Research, Beijing Cancer Hospital
Beijing, China, 100142