Trial intelligence / Profile preview

Irinotecan or 5-FU/LV in Pretreated Metastatic Colorectal Cancer

NCT00016952Phase 2

Key facts

Status: Completed
Start: Apr 2001
Primary completion: Apr 2004
Countries: 2
Sponsor: Cancer and Leukemia Group B
Modality: Small Molecules

Drugs: irinotecanfluorouracil
Conditions: metastatic colorectal cancer (mCRC)

Overview

Phase 2, open-label trial of irinotecan and fluorouracil in metastatic colorectal cancer (mCRC) (2 arms), sponsored by Cancer and Leukemia Group B. Primary endpoint: Tumor Response Rate up to 5 years. Started Apr 2001; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Group I (Prior Oxaliplatin)
Irinotecan IV over 90 minutes on day 1, every 3 weeks.
Group II (Prior Irinotecan + Oxaliplatin)
Leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2, every 2 weeks.

Who it enrols

Patients with metastatic colorectal adenocarcinoma who have progressed after oxaliplatin-based chemotherapy or irinotecan and oxaliplatin combination chemotherapy.

Endpoints

Primary

Tumor Response RateUp to 5 years

Secondary

Time to Tumor ProgressionUp to 5 years
Time to Treatment FailureUp to 5 years
Overall SurvivalUp to 5 years
Toxic EffectsUp to 5 years
Quality of LifeUp to 5 years

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