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
Overview
- Phase
- Phase 2
- Intervention
- Cisplatin
- Conditions
- Head and Neck Cancer
- Sponsor
- Amgen
- Enrollment
- 153
- Primary Endpoint
- Local Regional Control Rate at 2 Years
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Panitumumab Plus Chemoradiation
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.
Intervention: Cisplatin
Panitumumab Plus Chemoradiation
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.
Intervention: Standard Fractionation Radiotherapy
Panitumumab Plus Chemoradiation
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.
Intervention: Panitumumab
Chemoradiotherapy Alone
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
Intervention: Cisplatin
Chemoradiotherapy Alone
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
Intervention: Standard Fractionation Radiotherapy
Outcomes
Primary Outcomes
Local Regional Control Rate at 2 Years
Time Frame: 2 years
In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.
Secondary Outcomes
- Local Regional Control Rate at 6 Months and 12 Months(6 months and 12 months)
- Duration of Local-regional Control(From first dose up to 37 months)
- Overall Survival(From first dose date up to 37 months)
- Percentage of Participants With an Objective Response at 6 Months(6 months)
- Progression-Free Survival(From first dose date to 37 months)
- Percentage of Participants With a Complete Response at 6 Months(6 months)