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

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.

Conditions

• Head and Neck Cancer

Interventions

DRUG

carboplatin

DRUG

cisplatin

DRUG

docetaxel

DRUG

fluorouracil

DRUG

lapatinib ditosylate

GENETIC

cytogenetic analysis

GENETIC

fluorescence in situ hybridization

GENETIC

in situ hybridization

GENETIC

polymerase chain reaction

GENETIC

reverse transcriptase-polymerase chain reaction

OTHER

immunohistochemistry staining method

OTHER

laboratory biomarker analysis

PROCEDURE

conventional surgery

PROCEDURE

neoadjuvant therapy

RADIATION

fludeoxyglucose F 18

RADIATION

radiation therapy

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC

  lead NETWORK

Principal Investigators

• Ahmad Awada, MD, PhD · Jules Bordet Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-05-31

Primary Completion

2008-11-30

Completion

2009-03-31

Countries

• Belgium

Study Locations