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

NCT00983047 | Terminated Phase 2 DMC

• 1 other identifier: BT-IST-NSCLC-010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Advanced Non-Small Cell Lung Cancer

Keywords

Nimotuzumab; NSCLC; Docetaxel

Outcome Measures

Primary Outcomes (1)

• Median Survival Time

  12 months

Secondary Outcomes (5)

• Disease control rate

  12 months

• Time to progression

  12 months

• Safety of the Nimotuzumab and docetaxel (NCI CTC3.0)

  12 months

• Quality of life before and after the treatment (QLQ-C30)

  12 months

• Analysis EGFR expression, EGFR mutation and amplification, K-ras mutation in the tumor tissues

  12 months

Study Arms (2)

Docetaxel

ACTIVE COMPARATOR

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

Nimotuzumab and Docetaxel

EXPERIMENTAL

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

Interventions

Nimotuzumab and Docetaxel DRUG

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.

Also known as: Nimotuzumab

Docetaxel; Nimotuzumab and Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University School of Oncology, Beijing Institute for Cancer Research, Beijing Cancer Hospital

Beijing, 100142, China

Location

MeSH Terms

Interventions

nimotuzumab; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jie Wang

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 23, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

CN (1)