The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.
This research study involves the use of a combination of two chemotherapies, cisplatin and docetaxel, which have been known to shrink head and neck cancers and are a commonly used treatment for this type of cancer. This combination will then be followed by radiation and more chemotherapy. The purpose of this study is to see whether this combination of chemotherapy and radiation, with the addition of Cetuximab, can improve control of disease and collect information on what side effects this combination therapy may have. In addition, biologic factors (markers) will be studied that may help to predict and treat head and neck cancer patients in the future.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Docetaxel 75 mg/m\^2 IV over 1 hour, day 1
Cisplatin 75 mg/m\^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.
Cetuximab dose will be 250 mg/m\^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3).
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
Time frame: Up to 36 months
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
Time frame: Up to 36 months
Progression-free Survival (PFS)
PFS is an estimated percentage of participants without disease progression at two years (or three years) after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0. The two-year and three-year PFS ended up being the same in this study.
Time frame: Up to 36 months
2-year Overall Survival (OS)
Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.
Time frame: Up to 24 months
3-year Overall Survival (OS)
Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.
Time frame: Up to 36 months
Quality of Life (QOL)
Effect of treatment on acute and late QOL and functional status using Functional Assessment of Cancer Therapy-General (FACT-G) with FACT-Head and Neck (FACT-HN) subscale. The instructions to the participant were: "Below is a list of statements that other people with your illness have said are important. By circling one number per line, please indicate how true each statement has been for you during the past 7 days." The choices for each statement ranged from 0 (not at all) to 4 (very much). The FACT-G and FACT-Head and Neck total scores were computed by summing 27 and 39 questions respectively, for four subscales: physical well-being, social well-being, emotional well-being, and functional well-being. Questions for both assessments are phrased so that higher numbers/values indicate a better health state.
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Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies\>6 MV may be utilized when appropriate to boost target localized centrally.
Time frame: Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE