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

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT00498953
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • carboplatin — DRUG
  • cisplatin — DRUG
  • docetaxel — DRUG
  • fluorouracil — DRUG
  • lapatinib ditosylate — DRUG
  • cytogenetic analysis — GENETIC
  • fluorescence in situ hybridization — GENETIC
  • in situ hybridization — GENETIC
  • polymerase chain reaction — GENETIC
  • reverse transcriptase-polymerase chain reaction — GENETIC
  • immunohistochemistry staining method — OTHER
  • laboratory biomarker analysis — OTHER
  • conventional surgery — PROCEDURE
  • neoadjuvant therapy — PROCEDURE
  • fludeoxyglucose F 18 — RADIATION
  • radiation therapy — RADIATION

Study Details

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.

Key Dates

Start date
May 31, 2007
Status verified
Jul 2018
Primary completion
Nov 30, 2008
Completion
Mar 31, 2009

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Maximum tolerated dose of lapatinib ditosylate (Phase I)

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