Status:
COMPLETED
Study for Therapy of Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) With Cisplatin / Docetaxel or Oxaliplatin / Docetaxel
Lead Sponsor:
Krankenhaus Nordwest
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study compares two combinations of chemotherapy in patients with advanced or metastatic NSCLC: 50% of the patients are treated with cisplatin and docetaxel, the other 50% with oxaliplatin and doce...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01222312
Start Date
August 1 2008
End Date
November 1 2011
Last Update
November 29 2011
Active Locations (1)
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1
Krankenhaus Nordwest
Frankfurt am Main, Germany, 60488