Patients suffering from non-small cell lung cancer in an advanced stage and bad general condition
Conditions
Interventions
Trade Name: Taxotere
Product Name: Docetaxel
Pharmaceutical Form: Solution for infusion
Trade Name: Gemzar
Product Name: Gemcitabin
Pharmaceutical Form: Solution for infusion
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -histological or cytological proof of a non-small cell lung cancer (NSCLC), recently diagnosed or relapse after curative radiotherapy of operation -stage IIIb-"wet" (existence of malignant pleural or pericardial effusion) or IV (existence of distant metastases) according to UICC -ECOG performance status of 2 -detectable tumourous lesions, i.e. at least one lesion of >=1cm which is detectable by spiral-CT or MRT -no cytostatic treatment of the lung cancer including oral tyrosine kinase inhibitors ans antibodies -age >= 18 years -no other relevant pulmonal disease (FEV1 >=50% pp) -life expectancy of at least 12 weeks -adequate hematologic, renal, hepatic function according to the following definitions: •absolute count of neutrophiles >= 1,5*10^9 /l •platelets >=100*10^9/l •total bilirubine =60 ml/min - signed (written) informed consent - women of child-bearing age: negative pregnancy test - women of child-bearing age: willingness to use highly effective contraceptive methods (Pearl Index =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Chemotherapeutic pretreatment (including oral inhibitors of tyrosinkinase and antibodies) -percutaneous radiation therapy on the primary tumor or on the mediastinum during the preceding 12 months (elevated risk of pulmonary toxicity) -in case of existence of brain metastases: whole brain radiation must be completed for at least three days and neurologic symptoms must be completely under control with 12 mg of Dexamethason per day -Intolerance against Gemcitabin or Docetaxel -other malignomas apart from NSCLC which emerged during the preceding 5 years or had to be treated during the preceding 5 years (barring basalioma of the skin or carcinoma in situ of the uterine cervix -preexisting motor or sensory neurotoxicity >= grade 2 -severe concomitant disease or medical disturbance which impair the patient´s ability to receive the correct therapy according to the protocol. For example: active infections including HIV/AIDS, manifest cardiac insufficiency, higher grade cardiac arrhythmia (worse than atrioventricular block grade I), myocardial infarction during the last 6 months, unstable angina pectoris) -application of any other drug during the preceding 30 days that is not approved or that is tested in a clinical trial -pregnant women, breast-feeding women, patients that might get pregnant during the course of the trial. In all women of child-bearing age a negative pregnancy-test before inclusion and the use of a highly effective contraceptive method is obligatory. -any other condition or therapy which may mean harm to the patient according to the opinion of the investigator or may impair the accomplishment of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Number of completed cycles of chemotherapy (without progression of the underlying disease or inacceptable toxicity);Secondary Objective: Response rate according to RECIST criteria 1-year survival rate Median overall survival Progression-free survival Quality of life Treatment toxicity ;Primary end point(s): Number of completed cycles of chemotherapy (without progression of the underlying disease or inacceptable toxicity) | — |
Countries
Germany
Outcome results
None listed