drugset / Trial / NCT02508077

FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer

NCT02508077 ↗

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well fluorouracil, leucovorin calcium, and irinotecan hydrochloride (FOLFIRI) together with panitumumab work in treating patients with colorectal cancer that expresses the RAS and B-Raf proto-oncogene, serine/threonine kinase (BRAF) wild-type genes, has spread from the original site of growth to another part of the body (metastatic), resists the effects of treatment with prior cetuximab (or panitumumab) plus irinotecan hydrochloride-based therapy, and who have failed at least one subsequent non-anti-epidermal growth factor receptor (EGFR) containing treatment regimen. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as panitumumab, may block tumor growth in different ways by targeting certain cells. Giving FOLFIRI together with panitumumab may be an effective treatment for colorectal cancer.

Timeline

Start
2016-02-16
Primary completion
2017-09-13
Completion
2017-09-13

Outcome

Outcome not reported

Stopped (Enrollment): “Poor Accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule — Intravenous
Subject Leucovorin Small molecule — Oral
Subject Panitumumab Monoclonal antibody — Intravenous
Subject fluorouracil Small molecule — Intravenous

Indications