Study of Addition of Panitumumab to Chemoradiation Therapy in Patients With Locally Advanced Head and Neck Cancer

Amgen

Status and phase: Completed; Phase 2

Conditions: Squamous Cell Carcinoma; Head and Neck Cancer

Treatments: Drug: Panitumumab; Drug: Cisplatin; Radiation: Standard Fractionation Radiotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00500760

20062080

Details and patient eligibility

About

The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. The study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of Stage III or IVa-b (M0) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
• Eastern Cooperative Oncology Group (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-endothelial growth factor receptor (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Panitumumab Plus Chemoradiation

Experimental group

Description:

Participants received standard radiation therapy for 7 weeks and cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg on Days 1, 22 and 43.

Treatment:

Drug: Cisplatin

Drug: Panitumumab

Radiation: Standard Fractionation Radiotherapy

Chemoradiotherapy Alone

Active Comparator group

Description:

Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.

Treatment:

Drug: Cisplatin

Radiation: Standard Fractionation Radiotherapy