Everolimus, Erlotinib Hydrochloride, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer Previously Treated With Radiation Therapy

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT01332279
Phase
PHASE1
Status
Withdrawn

Conditions

  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • Recurrent Salivary Gland Cancer
  • Recurrent Squamous Cell Carcinoma of the Hypopharynx
  • Recurrent Squamous Cell Carcinoma of the Larynx
  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Verrucous Carcinoma of the Larynx
  • Recurrent Verrucous Carcinoma of the Oral Cavity
  • Salivary Gland Squamous Cell Carcinoma
  • Tongue Cancer

Eligibility Criteria

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

Interventions

  • everolimus — DRUG
    Given PO
  • erlotinib hydrochloride — DRUG
    Given PO
  • biopsy — PROCEDURE
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • immunohistochemistry staining method — OTHER
    Correlative studies
  • polyacrylamide gel electrophoresis — GENETIC
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies
  • external beam radiation therapy — RADIATION
    Undergo EBRT
  • microarray analysis — GENETIC
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of giving everolimus (RAD001) and erlotinib hydrochloride together with radiation therapy in treating patients with recurrent head and neck cancer previously treated with radiation therapy. RAD001 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving RAD001 and erlotinib hydrochloride together with radiation therapy may kill more tumor cells.

Key Dates

First listed
Apr 11, 2011
Start date
Apr 30, 2011
Status verified
Mar 2023
Primary completion
May 31, 2011
Completion
May 31, 2011

Study Design

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

Arms

  • Experimental: Treatment (enzyme inhibitor and radiation therapy)
    Patients receive RAD001 PO and erlotinib hydrochloride PO QD. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT BID 5 days a week for 5 weeks.

Primary Outcome Measure

MTD of RAD001, erlotinib and radiotherapy in the re-irradiation setting [ Time Frame: During the period of radiation treatment or within the first 2 weeks after the completion of radiotherapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in Philadelphia, PA

By research site
Fox Chase Cancer Center· Philadelphia, PA

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