- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00226239
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
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Pennsylvania
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15232
- University of Pittsburgh Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Stage III-IVB head and neck cancer, all sites, including unknown primary tumors (bulky stage II (T2N0) lesions of the base of tongue or hypopharynx and patients with stage II nasopharyngeal cancer are also eligible) Prior to study entry the resectability and alternative treatment options will be determined by a team composed of an Ear, Nose, and Throat Surgeon, a Radiation Oncologist and a Medical Oncologist. Stage determination, optimal local treatment, and its timing according to this protocol will be determined at this evaluation. Unequivocal demonstration of distant metastasis (M1) confers ineligibility
- Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas, or WHO types I-III of the nasopharynx
- Unidimensionally-measurable disease is required (RECIST)
- No prior chemotherapy, biologic/molecular targeted therapy (including any prior therapy which specifically and directly targets the EGFR pathway), or radiotherapy for head and neck cancer
- Prior surgical therapy will consist only of incisional or excisional biopsy and organ sparing procedures such as debulking of airway compromising tumors or neck dissection in a patient with an existing primary tumor (Any non-biopsy procedure must have taken place > 4 weeks but < 3 months of initiating protocol treatment)
- ECOG PS 0 or 1; 7. Organ & marrow function per protocol criteria and 8. Age of >=18 years
Exclusion Criteria:
- History of severe allergic reactions attributed to docetaxel or compounds of similar chemical or biologic composition to docetaxel, or other drugs formulated with polysorbate 80
- Uncontrolled intercurrent illness or significant history of uncontrolled cardiac disease
- Receiving any other investigational agents
- No history of prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, or malignancy that has been treated with a curative intent with a 5-year disease-free survival
- Significant baseline sensory or motor neurologic deficits (> grade I neuropathy); 6. HIV-positive patients and 7. Prior severe infusion reaction to a monoclonal antibody.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Head and neck cancer patients
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)
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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).
Другие имена:
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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Objective Response Rate (ORR)
Временное ограничение: Up to 36 months
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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.
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Up to 36 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Objective Response Rate (ORR)
Временное ограничение: Up to 36 months
|
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.
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Up to 36 months
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Progression-free Survival (PFS)
Временное ограничение: Up to 36 months
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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.
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Up to 36 months
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2-year Overall Survival (OS)
Временное ограничение: Up to 24 months
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Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.
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Up to 24 months
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3-year Overall Survival (OS)
Временное ограничение: Up to 36 months
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Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.
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Up to 36 months
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Quality of Life (QOL)
Временное ограничение: Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE
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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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Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
EGFR-related Serum Markers
Временное ограничение: Up to 36 months
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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.
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Up to 36 months
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Julie Bauman, MD, Univ of Pittsburgh
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 05-003
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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