- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00983047
Nimotuzumab Plus Docetaxel in Chemotherapy-Refractory/Resistant Patients With Advanced Non-Small-Cell Lung Cancer
Phase II Study of Nimotuzumab Plus Docetaxel in Chemotherapy-refractory/Resistant Patients With Advanced Non-small-cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Beijing, China, 100142
- Peking University School of Oncology, Beijing Institute for Cancer Research, Beijing Cancer Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Docetaxel
The chemotherapy treatment:Docetaxel was administered every 3 weeks 75mg/m2, efficacy will be evaluated after two cycles,the chemotherapy will be administered continually 2 cycles if the response is CR\PR\SD.
No more than 4 cycles chemotherapy was given.
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The chemotherapy treatment:Docetaxel was administered every 3 weeks 75 mg/m2, efficacy will be evaluated after two cycles,the chemotherapy will be administered continually 2 cycles if the response is CR\PR\SD. No more than 4 cycles chemotherapy was given. Nimotuzumab treatment: Dose of 200 mg intravenous infusion per week was continued after the end of chemotherapy until disease progression or unacceptable toxicity.
Other Names:
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Experimental: Nimotuzumab and Docetaxel
The chemotherapy treatment:Docetaxel was administered every 3 weeks 75mg/m2,efficacy will be evaluated after two cycles,the chemotherapy will be administered continually 2 cycles if the response is CR\PR\SD.No more than 4 cycles chemotherapy was given. Nimotuzumab treatment:Dose of 200mg intravenous infusion per week was continued after the end of chemotherapy until disease progression or unacceptable toxic. |
The chemotherapy treatment:Docetaxel was administered every 3 weeks 75 mg/m2, efficacy will be evaluated after two cycles,the chemotherapy will be administered continually 2 cycles if the response is CR\PR\SD. No more than 4 cycles chemotherapy was given. Nimotuzumab treatment: Dose of 200 mg intravenous infusion per week was continued after the end of chemotherapy until disease progression or unacceptable toxicity.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Median Survival Time
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to progression
Time Frame: 12 months
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12 months
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Disease control rate
Time Frame: 12 months
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12 months
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Safety of the Nimotuzumab and docetaxel (NCI CTC3.0)
Time Frame: 12 months
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12 months
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Quality of life before and after the treatment (QLQ-C30)
Time Frame: 12 months
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12 months
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Analysis EGFR expression, EGFR mutation and amplification, K-ras mutation in the tumor tissues
Time Frame: 12 months
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jie Wang, Peking University Cancer Hospital & Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Immunological
- Docetaxel
- Nimotuzumab
Other Study ID Numbers
- BT-IST-NSCLC-010
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.
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