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A Phase 2, Randomized Trial of Chemoradiation With or Without Panitumumab in Subjects With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Squamous Cell Carcinoma

Thank you

Trial Information

A Phase 2, Randomized Trial of Chemoradiation With or Without Panitumumab in Subjects With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck


Inclusion Criteria:



- Confirmed diagnosis of Stage III or IVa-b (M0) squamous cell carcinoma of the oral
cavity, oropharynx, hypopharynx or larynx

- ECOG performance status of 0 or 1 (you must be well enough to receive chemoradiation
therapy)

- You must be at least 18 years of age

- Your test results must show that your kidneys, liver and blood cells are working
adequately and that, if you are female, you are not pregnant

- You must have measurable disease

Exclusion Criteria:

- Cancer of the nasopharynx, sinus, salivary gland or skin

- History of another cancer (other than head and neck) unless treated with curative
intent and with no evidence of disease for more than 3 years, with the exception of
non-melanoma skin cancer or in situ cervical cancer

- Previous treatment with anti-EGFr antibody therapy or EGFr inhibitors

- Previous treatment for head and neck cancer, with chemotherapy, surgery (except nodal
sampling or biopsy) or radiotherapy

- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) within one year before you join the study

- Chronic obstructive pulmonary disease (pneumonia or respiratory decompensation)
resulting in hospitalization within 6 months of study screening

- History or evidence of interstitial lung disease (e.g. pneumonitis or pulmonary
fibrosis)

- Major surgery within 28 days of screening

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local-regional control rate

Outcome Time Frame:

at two years

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Finland: Lääkelaitos

Study ID:

20062080

NCT ID:

NCT00500760

Start Date:

October 2007

Completion Date:

November 2011

Related Keywords:

  • Head and Neck Cancer
  • Squamous Cell Carcinoma
  • Head and Neck Cancer
  • panitumumab
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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