Status:
WITHDRAWN
Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Biotech Pharmaceutical Co., Ltd.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Nimotuzumab (hR3) 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 b...
Detailed Description
Altered expression or constitutive activation of the epidermal growth factor receptor (EGFR/HER1/erbB1) commonly occurs in primary NSCLC, and is often a critical factor in progressive growth and resis...
Eligibility Criteria
Inclusion
- Subjects with pathologically or cytologically documented stage IIIB or IV NSCLC. Disease must be newly diagnosed .
- Presence of at least 1 uni-dimensionally measurable index lesion,with the longest diameter ≥ 20 mm using conventional computer tomography(CT)/magnetic resonance imaging(MRI)scan or ≥ 10 mm using spiral computed tomography scan.
- Age \> 18 and \< 65, with ECOG performance status 0-1,and Life expectancy of more than 3 months.
- functions of major organs (haemogram, heart, liver, kidney) are basically normal, White blood count ≥3.5 x 109/L with neutrophils ≥1.5 x 109/L, platelet count≥100 x 109/L, and hemoglobin ≥100g/L. Total bilirubin ≤1.5 times upper limit of normal (ULN) range; alkaline phosphatase(ALP)≤ 2.5 times ULN or ≤5 times ULN (liver metastasis); Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN or ≤ 5 times ULN (liver metastasis). serum creatinine ≤ 1.2 times ULN, blood urea nitrogen≤ 1.2 times ULN.
- both female and male patients must use adequate methods of contraception.
- without other malignancy history, except curative carcinoma in situ of cervix and skin basal cell carcinoma.
- willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion
- Previous radiotherapy（except the radiotherapy of brain metastasis）, Previous chemotherapy or anticancer biotherapy , Participation other clinical trials within 1 month prior to inclusion in the trial.
- With only unmeasureable lesion, ie, hydrothorax, ascites, lymphangitis carcinomatous, diffuse liver metastasis, bony metastasis; no measureable lesion or the lesion could not be determined.
- Pregnant or breast-feeding women or using a prohibited contraceptive method.
- With Symptomatic brain metastasis not controlled.
- with an uncontrolled seizure disorder, or active centre neurological disease, or Psychiatric disease affected cognitive ability; physiogenic or pathological dystrophinopathies, chronic diarrhea, cachexia.
- with significant history of cardiac disease, i.e., congestive heart failure, angina requiring medication, uncontrolled cardiac ventricular arrythmias, heart valve disease, serious myocardial infarction, uncontrolled hypertension.
- With other serious internal diseases or uncontrolled infection.
- With drug addition,ie,drug-taking,drug-taking for long time;with AIDS.
- With organ transplantation,or using adrenocortical hormone or immunosuppressive agents for long time.
- With history of serious allergic or allergy.
- Not fit for the clinical trial judged by the investigator.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00985998
Start Date
September 1 2009
End Date
August 1 2015
Last Update
August 19 2015
Active Locations (1)
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1
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100000