Neoplasms

All Conditions

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Cetuximab

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Induction chemotherapy consists of 3 cycles of cisplatin 75 mg/m\^2, on day 1, docetaxel 75 mg/m\^2, on day 1, and cetuximab weekly days 1,8,15, repeated every 21 days (cetuximab dose is 400 mg/m\^2 on day 1 and 250 mg/m\^2 on subsequent weekly treatments). After 3 cycles of induction, patients receive standard radiation 70 Gy/200 cGy/daily, 5 days/week with concurrent weekly cisplatin 30 mg/m\^2 and cetuximab 250 mg/m\^2. After completing radiation therapy, patients receive cetuximab weekly as maintenance therapy for 6 months (see section 5 for detailed treatment plan and dose modifications)

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).

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.

Radiation Therapy

Julie Bauman, MD

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.

Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer

A Phase II Trial of Docetaxel, Cetuximab (C225), and Cisplatin Followed by Radiation, Cetuximab, and Cisplatin in Locally Advanced Head and Neck Cancer

Evaluation of changes in serum markers (EGFR-related) before and after therapy in the above patient population, and expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers.

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.

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.

Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.

Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.

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.

Bristol-Myers Squibb

University of Pittsburgh

Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m\^2 day 1, cisplatin 75 mg/m\^2 day 1, and cetuximab 250 mg/m\^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m\^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m\^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.

Head and Neck Cancer Patients

Age, Continuous

Sex: Female, Male

Rita Johnson, Associate Director of Clinical Research Services

Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m\^2 day 1, cisplatin 75 mg/m\^2 day 1, and cetuximab 250 mg/m\^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m\^2), termed TPE, repeated every 21 days for three cycles

Treated with docetaxel 75 mg/m\^2 day 1, cisplatin 75 mg/m\^2 day 1, and cetuximab 250 mg/m\^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m\^2), termed TPE, repeated every 21 days for three cycles.

Objective Response Rate (ORR)

Docetaxel 75 mg/m\^2 day 1, cisplatin 75 mg/m\^2 day 1, and cetuximab 250 mg/m\^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m\^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m\^2 and cetuximab weekly (XPE).

two-year PFS

three-year PFS

All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.

Spots Global Cancer Trial Database for Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer

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