Non Small Cell Lung Cancer Clinical Trial
— TaxeloxOfficial title:
Multicenter Randomized Phase II Study for the Therapy of Locally Advanced or Metastatic NSCLC (Stage IIIB/IV) With Cisplatin/Docetaxel or Oxaliplatin/Docetaxel
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | November 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Krankenhaus Nordwest | Frankfurt/Main |
Lead Sponsor | Collaborator |
---|---|
Krankenhaus Nordwest |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response rate | staging every 2 months | No | |
Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | comparison of adverse events (all grades, grade 3/4) in the Cisplatin vs Oxaliplatin arm | every two weeks | Yes |
Secondary | quality of life | every 8 weeks | No | |
Secondary | progression free survival PFS | every 2 months | No | |
Secondary | overall survival OS | 6 months follow-up | No | |
Secondary | time to treatment failure TTF | every two weeks | No |
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