drugset / Trial / NCT00766142

Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

NCT00766142 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy given together with cetuximab works in treating patients undergoing surgery to remove peritoneal carcinomatosis from colorectal cancer.

Timeline

Start
2007-05-01
Primary completion
2013-09-17
Completion
2013-09-17

Outcome

Outcome not reported

Stopped: “In 2008, new data highlighted that Cetuximab had no efficacy in case of KRAS mutation. As such, eligibility criteria were revised and limited to KRAS wild-type. Inclusions were thus slown down considerably, and the trial was stopped.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody — Intravenous
Subject Leucovorin Small molecule — Intravenous
Subject Oxaliplatin Small molecule — Intravenous
Subject fluorouracil Small molecule — Intravenous