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Oxaliplatin and 5-FU/LV in Second-Line Metastatic Colorectal Cancer
NCT00008281Phase 3
Key facts
- Status
- Unknown
- Start
- Oct 2000
- Countries
- 2
- Sponsor
- Sanofi
- Modality
- DNA Intercalators/Alkylators
- Drugs
- oxaliplatin
- Conditions
- colorectal cancer (metastatic) (mCRC)
01
Overview
Phase 3, randomised, open-label trial of oxaliplatin in colorectal cancer (metastatic) (mCRC) (3 arms), sponsored by Sanofi. Primary endpoint: Overall Survival at 1 year. Status: unknown.
02
Design
3 arms- Study design
- RandomizedOpen-label
5-FU + LV
Leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 bolus and 600 mg/m2 continuous infusion on Days 1 and 2.
Oxaliplatin
Oxaliplatin 85 mg/m2 on Day 1.
FOLFOX4
Oxaliplatin 85 mg/m2 + Leucovorin 200 mg/m2 followed by 5-FU bolus/infusion on Day 1; 5-FU/LV repeated on Day 2.
03
Who it enrols
Patients with histologically confirmed metastatic adenocarcinoma of the colon or rectum who progressed during or within 6 months of first-line Saltz regimen (irinotecan, 5-FU, LV).
04
Endpoints
Primary
Overall Survival
Secondary
Response Rate
Time to Disease Progression
Time to tumor-related symptomatic worsening
Duration of Response
Safety Profile
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