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Docetaxel with or without Carboplatin in Second Line NSCLC
NCT00430651Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2004
- Primary completion
- May 2008
- Countries
- 1
- Sponsor
- Hellenic Oncology Research Group
- Modality
- DNA Intercalators/Alkylators
- Drugs
- carboplatin
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 3, randomised trial of carboplatin in non-small cell lung cancer (NSCLC) (2 arms), sponsored by Hellenic Oncology Research Group. Primary endpoint: Overall Survival at 1 year. Started Jul 2004; status: completed.
02
Design
2 arms- Study design
- Randomized
Docetaxel + Carboplatin
Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15 every 28 days for 6 cycles
Docetaxel
Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles
03
Who it enrols
Patients with histologically or cytologically confirmed NSCLC, ECOG 0-2, measurable disease, and adequate organ function, who have not previously received Docetaxel. Excludes patients with active cardiac disease, serious neurologic/psychiatric disease, active infections, or recent other malignancies.
04
Endpoints
Primary
Overall Survival
Secondary
Objective Response Rate
Toxicity
Health-Related Quality of Life
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