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Randomized Phase III Trial to Compare Radiation Therapy Alone With Radiation Therapy and Concomitant Anti-EGFr Antibody (C225) for Locally Advanced Squamous Cell Carcinomas of the Head and Neck


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Randomized Phase III Trial to Compare Radiation Therapy Alone With Radiation Therapy and Concomitant Anti-EGFr Antibody (C225) for Locally Advanced Squamous Cell Carcinomas of the Head and Neck


OBJECTIVES:

- Compare the rate of locoregional disease control maintained for 1 year in patients with
advanced squamous cell carcinoma of the oropharynx, hypopharynx, or larynx treated with
radiotherapy with or without concurrent cetuximab.

- Compare the response rates, progression-free survival and overall survival rates, and
quality of life in patients treated with these regimens.

- Compare acute and late toxicity of these regimens in these patients.

- Determine tumor epidermal growth factor receptor levels in patients treated with these
regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by Karnofsky
performance status (60-80% vs 90-100%), nodal stage (N0 vs N+), tumor stage (T1-3 vs T4),
and radiotherapy schedule (concurrent boost vs once daily vs twice daily).

Patients are randomized to 1 of 2 treatment arms:

- Arm I: Patients undergo radiotherapy beginning on day 1. Patients are assigned to 1 of
3 radiotherapy groups:

- Group 1: Patients undergo concurrent boost radiotherapy comprised of radiotherapy
once daily 5 days a week for 3.5 weeks followed by radiotherapy twice daily 5 days
a week for 2.5 weeks.

- Group 2: Patients undergo radiotherapy once daily 5 days a week for 7 weeks.

- Group 3: Patients undergo radiotherapy twice daily 5 days a week for 6-6.5 weeks.

- Arm II: Patients receive a test dose of cetuximab IV over 10 minutes on day 1. Patients
who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab
IV over 2 hours beginning 30 minutes after completion of test dose. Patients receive
maintenance cetuximab IV over 1 hour on day 8. Maintenance cetuximab repeats every week
for 7 courses. Beginning on day 8, patients undergo radiotherapy as in arm I
concurrently with maintenance cetuximab. There must be an hour interval between the
completion of cetuximab infusion and the start of any radiotherapy.

Patients with more than N1 neck disease at initial presentation undergo neck dissection 4-8
weeks after the completion of radiotherapy.

Quality of life is assessed before initiation of study therapy, at 8 weeks, and then every 4
months for 1 year.

Patients are followed at 8 weeks, every 4 months for 2 years, and then every 6 months for 3
years.

PROJECTED ACCRUAL: Approximately 416 patients (208 per arm) will be accrued for this study
within approximately 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven advanced squamous cell carcinoma of the oropharynx,
hypopharynx, or larynx

- Stage III OR

- Stage IV without distant metastases

- Measurable disease

- Tumor tissue available for immunohistochemical assay of epidermal growth factor
receptor expression

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 1 year

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT and SGPT no greater than 2 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 50 mL/min

- Calcium normal

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Medically able to withstand a course of definitive radiotherapy

- No medical or psychologic condition that would preclude informed consent or
compliance

- No other malignancy within the past 3 years except basal cell skin cancer or
preinvasive carcinoma of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior cetuximab or other murine monoclonal antibody

Chemotherapy:

- At least 3 years since prior systemic chemotherapy

- No concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to head and neck

- No other concurrent radiotherapy

Surgery:

- No prior surgery for indicator lesion except biopsy

- Study radiotherapy must not be a part of a postoperative regimen after primary
surgical resection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

James A. Bonner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000067468

NCT ID:

NCT00004227

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms

Name

Location

Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Kimball Medical CenterLakewood, New Jersey  08701
ImClone Systems, IncorporatedSomerville, New Jersey  08876