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ALIMTA + Oxaliplatin vs FOLFOX4 in First-Line Colorectal Cancer
NCT00166465Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2003
- Primary completion
- Jun 2006
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Small Molecules
- Drugs
- pemetrexed
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, randomised, open-label trial of pemetrexed in colorectal cancer (CRC) (2 arms), sponsored by Mayo Clinic. Primary endpoints: Maximum Tolerated Dose, Recommended Phase 2 Dose and 1 more. Started Aug 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
ALIMTA + Oxaliplatin
ALIMTA plus Oxaliplatin with folate and vitamin B-12 supplementation
FOLFOX 4
Oxaliplatin plus 5-Fluorouracil and Leucovorin
03
Who it enrols
Patients with locally advanced unresectable or Stage IV colorectal cancer, no prior chemotherapy for advanced disease (adjuvant allowed if > 6 months ago), and adequate organ function.
04
Endpoints
Primary
Maximum Tolerated Dose
Recommended Phase 2 Dose
Objective Response Rate
Secondary
Side Effects
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