Treatment of metastatic non small cell lung cancer (NSCLC) MedDRA version: 8.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS
Conditions
Interventions
Trade Name: Taxotere 80 mg
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOCETAXEL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Kliniken Essen Mitte
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or cytologically proven inoperable non small cell lung cancer stage IV without prior treatment with chemotherapy (1st-line), except adjuvant or neo-adjuvant chemotherapy for treatment of NSCLC that was administered at least two years prior to randomisation in this study. -Patients with a measurable disease, i.e. at least one measurable lesion, which can be visualized by means of clinical radiologic procedures (x-ray, CT) according to RECIST. -Age = 18 years. -Life expectancy = 12 weeks. -General condition according to ECOG Perfomance Status less than or equal to 2. -effective contraception in men and women if the possibility of conception is given (oral contraceptives with estrogen and gestagen (no minipill), vaginal ring pessary, contraceptive plaster, estrogen-free ovulation inhibitor, hormonal intrauterine device with progesterone, 3-months injectables with depot gestagen, hormone releasing implants (contraceptive rod with progesterone), abstinence or vasectomised partner for women and respectively abstinence or vasectomy in men). -Adequate haematological, renal and hepatic function according to the following definitions: -absolute neutrophils (count) = 2 x 10\9 /l. -Platelets = 100 x 10/9 /l. -Haemoglobin = 10g/dl. -Transaminases (ASAT, ALAT) less than or equal to 1,5 x UNL, without proof of liver metastasis. -Alkaline phosphatases less than or equal to 2.5 x UNL. -Total bilirubin less than or equal to UNL. -Creatinine less than or equal to 1.5 x UNL or glomerular filtration rate = 60 ml/min (evaluated according to the Cockroft-Gault formula). -Written informed consent. 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: -History or presence of any neoplasia other than NSCLC. Exceptions are nonmelanomatous skin cancers and curatively treated carcinoma in situ of the cervix. -Preexisting motoric or sensorial neuropathy >grade 1. -Preexisting infection (e.g. pneumonia, acute exacerbation of a chronic bronchitis etc.). -Serious concomitant disease or medical disorder, which could affect the capacity of the patient to receive therapy in compliance with the protocol. -Administration of other chemotherapeutical drugs during the participation in the study. -Contraindication/hypersensitivity to the study drugs (Docetaxel, Gemcitabine, Cisplatin) or concomitant drugs. -Chemotherapeutical pretreatment due to metastatic NSCLC. -Permanent therapy with oral glucocorticoid and, respectively, additional immunosuppression. -Manifest heart failure, arrhythmia of higher grades, myocardial infarction within six months prior to randomisation. -Uncontrolled hypertension (limit: 200/120 mmHg, measured at least twice within 24 hours). -Glomerular filtration rate < 60 ml / min (evaluated according to the Cockroft-Gault formula). -Relevant labyrinthine hearing loss. -Known epilepsy. -Symptomatic brain filiae. -Pregnant or breast-feeding women. -Foreseeable insufficient patient compliance. -Any other condition or therapy, which is considered to be a possible risk for the patient in the opinion of the attending physician or could affect the realisation or objectives of the clinical trial. -Any other medical, psychological or other condition which restricts the patient’s capability to give valid informed consent to participate voluntarily in this study. -Participation in another clinical trial within 30 days prior to randomisation in this study and, respectively, participation in another clinical trial for the course of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the efficacy and tolerability between two platinum-free therapeutic regimens in patients with metastatic non small cell lung cancer and to show that the Taxotere treatment arm is not inferior to the Gemzar treatment arm with regard to progression free survival.;Secondary Objective: Secondary objectives are the determination of / comparison between both treatment arms concerning: Toxicity, response rate, overall survival, quality of life. ;Primary end point(s): The primary analysis variable is progression free survival after protocol defined therapy (one complete course of Docetaxel or Gemcitabine). Progression free survival is defined as the interval from the date of randomisation to the first documented progression or death. | — |
Countries
Germany
Outcome results
None listed