drugset / Trial / NCT01847326

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer

NCT01847326

NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin followed by chemoradiation in treating patients with recurrent head and neck cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, fluorouracil, and hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel albumin-stabilized nanoparticle formulation followed by chemoradiation therapy may be an effective treatment for head and neck cancer.

Timeline

Start
2013-03-26
Primary completion
2024-01-22
Completion
2024-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 10 mg/m2 Intravenous
Subject Paclitaxel Small molecule 20 mg/m2 Intravenous
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous
Background Carboplatin Small molecule Intravenous
Background Hydroxyurea Other / unclassified Oral
Background fluorouracil Small molecule Intravenous