drugset / Trial / NCT00498953

Combination Chemotherapy and Radiation Therapy With or Without Lapatinib in Treating Patients With Locally Advanced Cancer of the Larynx or Hypopharynx

NCT00498953

RandomizedOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, 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. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with radiation therapy, with or without lapatinib, before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed or eliminate the need for surgery. PURPOSE: This phase I/II trial is studying the side effects and best dose of combination chemotherapy given together with radiation therapy with or without lapatinib and to see how well it works in treating patients with locally advanced cancer of the larynx or hypopharynx.

Timeline

Start
2007-05
Primary completion
2008-11
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule
Subject Cisplatin Other / unclassified Intravenous
Subject Docetaxel Small molecule Intravenous
Subject fluorouracil Small molecule Intravenous
Subject lapatinib ditosylate Small molecule 500 mg Oral

Indications