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A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)


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

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Trial Information

A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)


Inclusion Criteria:



- Man or woman at least 18 years old.

- Histologically or cytologically confirmed metastatic and/or recurrent squamous cell
carcinoma (or its variants) of the head and neck.

- Diagnosis of metastatic disease and/or recurrent disease following locoregional
therapy and determined to be incurable by surgery or radiotherapy.

- Subjects who have received radiation as primary therapy are eligible if locoregional
recurrence is in the field of radiation and has occurred ≥6 months after the
completion of radiation therapy. Subjects whose locoregional recurrence is solely
outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months
after the completion of radiation therapy.

- Measurable and non-measurable disease.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

- History or known presence of Central Nervous System (CNS) metastases.

- History of another primary cancer, except: curatively treated in situ cervical
cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor
curatively treated with no known active disease present and no treatment administered
for ≥ 2 years before randomization.

- Nasopharyngeal carcinoma.

- Prior systemic treatment for metastatic and/or recurrent SCCHN

- Prior cisplatin containing induction chemotherapy followed by cisplatin containing
chemoradiotherapy

- Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with
small molecule EGFr inhibitors

- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) less than or equal to 1 year prior to randomization. History of
interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of
interstitial lung disease on baseline chest computerized tomography (CT) scan.

- Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0

- Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events
(CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program])

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:

Overall Survival

Outcome Description:

Time from randomization to death

Outcome Time Frame:

Upto 56 months

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica)

Study ID:

20050251

NCT ID:

NCT00460265

Start Date:

May 2007

Completion Date:

September 2012

Related Keywords:

  • Recurrent and/or Metastatic Head and Neck Cancer
  • Squamous Cell Carcinoma
  • Epidermal Growth Factor
  • Epidermal Growth Factor Receptor
  • SCCHN
  • Metastatic Head and Neck Cancer
  • EGFr
  • Head and Neck Cancer
  • Recurrent Head and Neck Cancer
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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