drugset / Trial / NCT01652196

Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer

NCT01652196

Phase 2 Completed 56 enrolled John Hays Sanofi · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well giving aflibercept together with combination chemotherapy works in treating patients with previously untreated colon or rectal cancer that is metastatic or locally advanced and cannot be removed by surgery. Aflibercept may stop the growth of colon or rectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving aflibercept together with combination chemotherapy may kill more tumor cells

Timeline

Start
2012-11-14
Primary completion
2019-08-06
Completion
2022-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic 4 mg/kg Intravenous
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject Levoleucovorin Unknown 100 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous