Back to resultsNimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab and chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring nimotuzumab, non-small cell lung cancer, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nimotuzumab
Arm Description
Outcomes
Primary Outcome Measures
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
Secondary Outcome Measures
To determine the complete response rate、partial rate、disease response rate、disease control rate in the patients subject to treatment
Full Information
NCT ID
NCT00985998
First Posted
September 27, 2009
Last Updated
August 18, 2015
Sponsor
Biotech Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00985998
Brief Title
Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer
Official Title
Phase 1 Study of Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
no paticipants enrolled
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotech Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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 non-small cell lung cancer (NSCLC).
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 resistance to normal mechanisms of cell death. Epidermal growth factor receptor expression in lung cancer has been correlated with tumor aggressiveness. Clinical trials already suggest that EGFR targeted therapy may improve the antitumor activity of chemotherapy for treatment of lung carcinoma. Monoclonal antibodies specific to EGFR can be combined safely and effectively with chemotherapy. Nimotuzumab (hR3) is a humanized monoclonal antibody (mAb) that binds to the EGFR. In preclinical studies the antibody has shown potent antitumor activity. A previous phase II study in children with high grade brain tumors showed activity of Nimotuzumab as a monotherapeutic agent, even in prognostic very unfavourable diffuse, intrinsic pontine glioma. No drug related side effects were reported. Nimotuzumab (hR3) in combination with radiotherapy for treatment of locally advanced squamous cell carcinomas of the head and neck resulted in high rates of antitumor response, and was accompanied by a favourable safety profile.
This is a dose-escalation study of Nimotuzumab. Nimotuzumab in combination with chemotherapy will be administered to the patients with advanced NSCLC. 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 results of the 6th, 12th, 18th and the 22th week should be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
nimotuzumab, non-small cell lung cancer, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nimotuzumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab and chemotherapy
Other Intervention Name(s)
Nimotuzumab
Intervention Description
The chemotherapy treament：docetaxel( 75mg/m2/d,every21days,for4~6cycles) and cisplatin(total dose 75mg/m2 on day 2,3,4,every21days,for4~6cycles).
the nimotuzumab treatment:3 levels (200mg/w,400mg/w,600mg/w,weekly,for12~18 weeks).
Primary Outcome Measure Information:
Title
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
Time Frame
within study period
Secondary Outcome Measure Information:
Title
To determine the complete response rate、partial rate、disease response rate、disease control rate in the patients subject to treatment
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, Professor
Organizational Affiliation
86-10-87788121
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
12. IPD Sharing Statement
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Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer
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