Multicenter Randomized Phase II Study for the Therapy of Locally Advanced or Metastatic NSCLC (Stage IIIB/IV) With Cisplatin/Docetaxel or Oxaliplatin/Docetaxel
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
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.
Inclusion Criteria:
- histologically or cytologically confirmed NSCLC stage IIIB or IV.
- no previous chemotherapy in metastatic state
- male and female patients aged > 18 years
- ECOG ≤ 2
- Leukocytes > 3.000/µl
- Thrombocytes > 100.000/µl
- Serum creatinine ≤ 1.25x normal value, or Creatinine Clearance > 45 ml/min
- previous radiation < 25% bone marrow region allowed. Previous radiation of whole
pelvis not allowed
- parallel radiation allowed, if target lesion outside of radiation field
- written informed consent
- life expectancy > 3 months
Exclusion Criteria:
- hypersensibility against Cisplatin, Oxaliplatin or Docetaxel
- Neoadjuvant or adjuvant chemotherapy within the last 6 months
- radiation within the last 28 days
- severe systemic comorbidities
- Cardiomyopathy or cardiac insufficiency stage II-IV according to NYHA
- malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of
the cervix uteri, adequately treated skin basal cell carcinoma)
- brain metastases
- severe non-surgical comorbidities or acute infection
- peripheral polyneuropathy > NCI grade II
- severe liver dysfunction AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)
- participation in parallel trial
- pregnancy and lactation
- reduced hearing
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response rate
Outcome Time Frame:
staging every 2 months
Safety Issue:
No
Principal Investigator
Elke Jäger, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Krankenhaus Nordwest
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
S417
NCT ID:
NCT01222312
Start Date:
August 2008
Completion Date:
November 2011
Related Keywords:
- Non Small Cell Lung Cancer
- advanced NSCLC
- oxaliplatin
- cisplatin
- docetaxel
- locally advanced or metastatic non small cell lung cancer (stage IIIB-IV)
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
