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Trimetrexate With Leucovorin in Newly Diagnosed Metastatic Osteosarcoma
NCT00003776Phase 2
Key facts
- Status
- Completed
- Start
- Dec 1998
- Primary completion
- Mar 2000
- Countries
- 1
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Modality
- Small Molecules
- Conditions
- osteosarcoma (OS)
01
Overview
Phase 2, open-label, single-arm trial of trimetrexate glucuronate in osteosarcoma (OS), sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoints: Efficacy of oral trimetrexate glucuronate with simultaneous leucovorin calcium protection at week 4 and Toxicity of the regimen up to 3 years. Started Dec 1998; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Trimetrexate Window Therapy
Trimetrexate + Leucovorin induction, followed by surgery and standard maintenance chemotherapy
03
Who it enrols
Patients aged 30 and under with newly diagnosed, histologically confirmed high-grade metastatic osteosarcoma, with no prior chemotherapy, radiotherapy, or resection.
04
Endpoints
Primary
Efficacy of oral trimetrexate glucuronate with simultaneous leucovorin calcium protection
Toxicity of the regimen
Secondary
Correlation of response with in vitro determinants of chemotherapy resistance
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