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Gemcitabine + Carboplatin or Paclitaxel + Carboplatin in Metastatic NSCLC
NCT00054392Phase 3
Key facts
- Status
- Withdrawn
- Start
- Sep 2001
- Primary completion
- Sep 2001
- Countries
- 1
- Sponsor
- Fox Chase Cancer Center
- Modality
- DNA Intercalators/Alkylators
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 3, randomised, open-label trial in non-small cell lung cancer (NSCLC) comparing Arm I: Gemcitabine + Carboplatin, Arm II: Gemcitabine + Paclitaxel and Arm III: Paclitaxel + Carboplatin (3 arms). Primary endpoint: Overall Survival. Planned start Sep 2001; status: withdrawn.
02
Design
3 arms- Study design
- RandomizedOpen-label
Arm I: Gemcitabine + Carboplatin
Gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 15-30 minutes on day 1.
Arm II: Gemcitabine + Paclitaxel
Gemcitabine IV over 30 minutes on days 1 and 8 and paclitaxel IV over 3 hours on day 1.
Arm III: Paclitaxel + Carboplatin
Paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1.
03
Who it enrols
Adults with stage IIIB, IV, or recurrent NSCLC, ECOG 0-1, adequate organ function, no prior chemotherapy for advanced disease, and no unstable brain metastases.
04
Endpoints
Primary
Overall Survival
Secondary
Overall Response Rate
Time to Progression
Quality of Life
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