Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer

NCT00985998 | Withdrawn Phase 1

• 1 other identifier: BT-NSCLC-T-0902
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-small Cell Lung Cancer

Keywords

nimotuzumab; non-small cell lung cancer; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.

  within study period

Secondary Outcomes (1)

• To determine the complete response rate、partial rate、disease response rate、disease control rate in the patients subject to treatment

  3 months

Study Arms (1)

Nimotuzumab

EXPERIMENTAL

Drug: Nimotuzumab and chemotherapy

Interventions

Nimotuzumab and chemotherapy DRUG

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).

Also known as: Nimotuzumab

Nimotuzumab

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

nimotuzumab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yuankai Shi, Professor

  86-10-87788121

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2009
• First Posted: September 29, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

CN (1)