Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Johnny Kao
Study ID
NCT00970502
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Cancer of the Head
  • Cancer of the Larynx
  • Cancer of the Neck
  • Cancer of the Pharynx
  • Paranasal Sinus Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib + celecoxib — DRUG
    In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression

Study Details

There is no optimal treatment for patients with recurrent head and neck cancer after previous radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10 months. Surgery is not always possible and often cannot remove every cancerous cell. On the other hand, reirradiation with chemotherapy cures approximately 25 to 30% of patients but has significant toxicity with as many as 15 to 20% suffering from life-threatening or fatal complications. Therefore, less toxic and more effective reirradiation regimens are urgently needed. There are extensive data from animal studies and preliminary human studies showing that blocking epidermal growth factor receptor (EGFR) and COX-2 enhances radiation effect and is more effective than either treatment alone. Erlotinib is a FDA approved oral inhibitor of EGFR and celecoxib is a FDA approved COX-2 inhibitor. Both have been well studied in humans and appear to have less severe toxicity than conventional chemotherapeutic agents.

Key Dates

First listed
Sep 2, 2009
Start date
Feb 28, 2007
Status verified
Feb 2017
Primary completion
Nov 30, 2010
Completion
Nov 30, 2010

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: erlotinib + celecoxib

Primary Outcome Measure

Toxicity [ Time Frame: 30 DAYS ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai School of MedicineNew YorkNew York10029-

Find similar trials in New York, NY

By research site
Mount Sinai School of Medicine· New York, NY

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