Study for Therapy of Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) With Cisplatin / Docetaxel or Oxaliplatin / Docetaxel

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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 docetaxel. cisplatin is today the standard therapy, but the toxicity profile is often not tolerable. Especially in elderly patients or patients with comorbidities, oxaliplatin based chemotherapy may have lower toxicities but comparable or even better response rates.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Krankenhaus Nordwest
• Treatments: Cisplatin; Docetaxel; Oxaliplatin

Criteria

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