drugset / Trial / NCT00988897

Colorectal Cancer RECHALLENGE

NCT00988897 ↗

Phase 2 Withdrawn Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Primary Objective: * To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6) will provide a clinical disease control rate (DCR) of at least 20% at the end of the chemotherapy. Secondary Objective: * To evaluate other measures of tumour's responses and safety.

Timeline

Start
2009-10
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Bevacizumab Monoclonal antibody — Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications