Lung cancer remains the leading cause of cancer-related death in men and has increased its incidence in women over the past decades (protocol page 9). Data from both meta-analysis and clinical trials have provided solid evidence that cisplatin based chemotherapy improves survival, quality of life and is cost-effective when compared to best supportive care (pp9). The side effects of cisplatin limit its use, especially in older patients with concomittant cardio respiratory disease (pp15).
Conditions
Interventions
Trade Name: Erbitux 5mg/ml
Product Name: Erbitux
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
C
Sponsors
University of Heidelberg, Klinikum Mannheim, Dep Surgery/Thoracical Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following inclusion criteria: 1. Patients must have signed an informed consent prior to beginning protocol specific procedures. 2. Male or female patients, age = 18 years (female patients of childbearing potential must have a negative pregnancy test at study entry). 3. Patients must have histologically or cytologically confirmed stage IIIB (not eligible for radiotherapy) or stage IV NSCLC. 4. Patients must have a WHO performance status of 0, 1, or 2. 5. Patients must have adequate hematological and biochemical functioning as evidenced by the following: - hemoglobin = 9 g/dL - white blood cell count (WBC) = 3,500/mm3, - absolute neutrophil count = 2,000/mm3, - platelet count = 100,000/mm3, - creatinine = 2.0 mg/dL or creatinine clearance = 60 mL/min, - total bilirubin = 1.5 x ULN - AST and/or ALT = 1.5 x ULN - alkaline phosphatase = 5 x ULN 6. Patients must have at least one measurable or evaluable tumor lesion (pp 21). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following patients will be excluded from the study: 1. Pregnant or lactating women or women of childbearing potential not using effective contraception. 2. Prior chemo- or tumor-targeted immunotherapy. 3. Brain metastases. 4. Prior radiotherapy to measurable lesions. 5. Peripheral neuropathy NCI grade > 2 (pp 21-22).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the clinical practicability of two chemotherapeutic regimens defined as a combined score of clinical relevant hematological toxicity (thrombocytopenia CTC grade 3-4 and at least one transfusion during the actual cycle, anemia CTC grade 3-4 and at least one blood transfusion during the actual cycle, febrile neutropenia CTC grade 3-4 and i.v. administration of antibiotics for treatment) plus clinical relevant skin reactions (the occurrence of clinical relevant skin reactions with CTC grade 3 or 4 and with the need to discontinue cetuximab treatment according to the decision algorithm described in section 4.3.2.1) (pp 19).;Secondary Objective: The following secondary objectives will be evaluated in the same patient population: • Overall and 1-year survival • Response rate • Time to progression • General safety profile • Quality of life • Costs of treatment (pp 19-20) ;Primary end point(s): see: main objectives | — |
Countries
Germany, Lithuania
Outcome results
None listed