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Docetaxel/Pemetrexed in NSCLC
NCT00684099Phase 2
Key facts
- Status
- Completed
- Start
- May 2006
- Primary completion
- May 2009
- Countries
- 1
- Sponsor
- Hellenic Oncology Research Group
- Modality
- Small Molecules
- Drugs
- docetaxelpemetrexed
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, open-label, single-arm trial of docetaxel and pemetrexed in non-small cell lung cancer (NSCLC), sponsored by Hellenic Oncology Research Group. Primary endpoints: Dose Limiting Toxicity at 2 years and Maximum Tolerated Dose at 2 years. Started May 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Docetaxel + Pemetrexed
Combination of Docetaxel and Pemetrexed administered IV every 3 weeks.
03
Who it enrols
Patients with histologically confirmed inoperable (stage IIIB-IV) NSCLC, aged 18 or older, with WHO performance status 0-2. Phase I allows prior platinum chemotherapy; Phase II requires patients to be previously untreated with docetaxel and pemetrexed.
04
Endpoints
Primary
Dose Limiting Toxicity
Maximum Tolerated Dose
Secondary
Objective Response Rate
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