Multicenter Randomized Phase II Study for the Therapy of Locally Advanced or Metastatic NSCLC (Stage IIIB/IV) With Cisplatin/Docetaxel or Oxaliplatin/Docetaxel
Cispaltin based chemotherapies are standard for palliative first-line therapy in patients
with advanced or metastatic NSCLC. Due to contraindications to cisplatin, this substance can
not be used in a high number of patients. Especially in elderly patients, patients with
comorbidities and patients with reduced general condition, cisplatin is a therapy which
often induces intolerable toxicities. Thus, therapy often has to be interrupted or finished
prematurely. Due to its favorable toxicity profile, oxaliplatin can be used also for the
treatment of elderly patients and patients with comorbidities. Based on toxicity data from a
phase II study of our group in patients with gastric cancer, the dosage for
oxaliplatin/docetaxel was adopted for this actual study. In previous phase II trials,
response rates of oxaliplatin based combination chemotherapies were comparable to those with
cisplatin in patients with metastatic NSCLC.
In this study we will analyse, if a oxaliplatin based combination chemotherapy has a more
tolerable toxicity profile and comparable or even better response rate in comparison to a
cisplatin based chemotherapy. 44 patients in each arm will either be treated with a maximum
of 6 cycles cisplatin/docetaxel or a maximum of 8 cycles oxaliplatin/docetaxel.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
staging every 2 months
Elke Jäger, Prof. Dr.
Germany: Federal Institute for Drugs and Medical Devices