Nimotuzumab Plus Docetaxel in Chemotherapy-Refractory/Resistant Patients With Advanced Non-Small-Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Biotech Pharmaceutical Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biotech Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00983047
First received: September 21, 2009
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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. Nimotuzumab has demonstrated a unique clinical profile, where anti-tumor activity was observed in absence of severe skin, renal, gastrointestinal mucosa toxicities commonly associated with EGFR-targeting antibodies. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in many countries. The investigators compared docetaxel plus nimotuzumab with docetaxel alone in chemotherapy-refractory/resistant patients with advanced EGFR-positive non-small-cell lung cancer to assess the efficacy and safety.


Condition Intervention Phase
Advanced Non-Small Cell Lung Cancer
Drug: Nimotuzumab and Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Nimotuzumab Plus Docetaxel in Chemotherapy-refractory/Resistant Patients With Advanced Non-small-cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Biotech Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Median Survival Time [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease control rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety of the Nimotuzumab and docetaxel (NCI CTC3.0) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quality of life before and after the treatment (QLQ-C30) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Analysis EGFR expression, EGFR mutation and amplification, K-ras mutation in the tumor tissues [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: August 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Nimotuzumab and Docetaxel

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 Name: Nimotuzumab
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.

Drug: Nimotuzumab and Docetaxel

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 Name: Nimotuzumab

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 200mg per week,at least 12 weeks.The patients'hematology and biochemistry examination will be monitored weekly, a physical exam and assessment of the tumor will be performed and every 6 weeks. The patients will be followed up every 3 months to evaluate the survival.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological/cytological confirmed Non-small cell lung cancer
  2. EGFR expression is positive (Immunohistochemistry)
  3. Locally advanced or advanced NSCLC patients(Stage IIIb \ IV)
  4. 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).
  5. The last dose of chemotherapy must be finished at least 3 weeks before the study, the acute toxicity of chemotherapy must be recovery.
  6. 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. )
  7. 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.
  8. ECOG performance status 0-2.
  9. Life expectancy ≥ 12 weeks.
  10. 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;
  11. No history of clinically significant or uncontrolled cardiac disease, normal electrocardiogram(ECG).
  12. 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.
  13. Signed informed consent and submit to the organization of research

Exclusion Criteria:

  1. Brain metastasis and with symptom
  2. Previously treatment regimen including:Docetaxel, anti EGFR monoclonal antibody,anti-angiogenesis targeted medicine,small molecule tyrosine kinase inhibitor(TKIs)
  3. Receiving other anti-cancer medicine treatment during the study
  4. Uncontrolled pleural effusion、seroperitoneum、pericardial effusion
  5. Serious illness or other malignancies diagnosed within the past five years.
  6. Patients with any serious active infection
  7. The second primary malignant tumor
  8. Serious accompanying disease would influenced the study (such as cardiac disease,Diabetes mellitus etc)
  9. Contraindication of hormone therapy
  10. Previous definable peripheral neuropathy and with symptom
  11. Do not sign informed consent form
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983047

Contacts
Contact: Jie Wang 8610-88196660 wangjie_cc@yahoo.com
Contact: Jun Zhao 8610-88196660 ohjerry@163.com

Locations
China
Peking University School of Oncology, Beijing Institute for Cancer Research, Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Contact: Jie Wang    8610-88196660    wangjie_cc@yahoo.com   
Contact: Jun Zhao    8610-88196660    ohjerry@163.com   
Principal Investigator: Jie Wang         
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Jie Wang Beijing Cancer Hospital
  More Information

No publications provided

Responsible Party: Jie Wang, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT00983047     History of Changes
Other Study ID Numbers: BT-IST-NSCLC-010
Study First Received: September 21, 2009
Last Updated: September 23, 2009
Health Authority: China: Food and Drug Administration
China: Ethics Committee

Keywords provided by Biotech Pharmaceutical Co., Ltd.:
Nimotuzumab
NSCLC
Docetaxel

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014