- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00049101
Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
A Phase I/II Study Of OSI-774 In Combination With Oxaliplatin, And 5-Fluourouracil In Patients With Metastatic Colorectal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining erlotinib with combination chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib with oxaliplatin, leucovorin, and fluorouracil in treating patients who have metastatic colorectal cancer.
Обзор исследования
Статус
Условия
Подробное описание
OBJECTIVES:
- Determine the maximum tolerated dose of erlotinib when administered with oxaliplatin, leucovorin calcium, and fluorouracil in patients with metastatic colorectal cancer.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine any antitumor activity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the objective response rate and response duration in patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a dose-escalation study of erlotinib.
- Phase I: During the first week of the first course only, patients receive oral erlotinib daily alone. Patients then begin the regular schedule comprising oral erlotinib daily, oxaliplatin IV over 2 hours on day 1, and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 2 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive erlotinib at the MTD plus oxaliplatin, leucovorin calcium, and fluorouracil as in phase I. Erlotinib may be administered alone if toxicity is caused by oxaliplatin, leucovorin calcium, and fluorouracil.
Patients are followed for at least 6 months or until disease progression.
PROJECTED ACCRUAL: A total of 4-18 patients will be accrued for phase I of this study within 1-4 months. A total of 50 patients will be accrued for phase II of this study within 10 months.
Тип исследования
Фаза
- Фаза 2
- Фаза 1
Контакты и местонахождение
Места учебы
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New York
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New York, New York, Соединенные Штаты, 10021
- Memorial Sloan-Kettering Cancer Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
DISEASE CHARACTERISTICS:
Histologically confirmed colon or rectal cancer
- Metastatic or unresectable disease
Unidimensionally measurable disease required for phase II only
- At least 20 mm by x-ray, CT scan, MRI, or photography
The following are not considered measurable:
- Pleural effusion or ascites
- Osteoblastic lesions
- Evidence of disease on bone scan alone
- Progressive irradiated lesions alone
- Bone marrow involvement
- Brain metastases
- Malignant hepatomegaly by physical exam alone
- Chemical markers (e.g., carcinoembryonic antigen)
Recurrent disease after surgery or radiotherapy is considered measurable as long as the following criteria are met:
- At least 4 weeks since prior surgery or radiotherapy
- Measurable disease exists outside the radiation port or clear progression exists within the radiation port
- Tissue accessible for immunohistochemical evidence of epidermal growth factor receptor expression from a metastatic site (phase II only)
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 3 months
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin normal
- AST/ALT no greater than 2.5 times upper limit of normal
Renal
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No unstable angina pectoris
- No symptomatic congestive heart failure
- No cardiac arrhythmia
- No uncontrolled hypertension (systolic blood pressure greater than 150 mm Hg)
Opthalmic
- No abnormalities of the cornea (e.g., severe dry eye syndrome or Sjogren's syndrome)
- No congenital abnormality (e.g., Fuch's dystrophy)
- No abnormal slit-lamp examination using vital dye (e.g., fluorescein or Bengal-Rose)
- No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear-production test)
- Mild dry eye syndrome allowed if patient can use artificial tears and ophthalmologist concurs
Gastrointestinal
- No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
- No active peptic ulcer disease
Other
- Must be able and willing to undergo a mediport insertion
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except previously excised and inactive basal cell or squamous cell skin cancer
- No prior allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib or other study drugs (e.g., epidermal growth factor inhibitors like cetuximab)
- No significant traumatic injury within the past 3 weeks
- No peripheral neuropathy grade 2 or greater
- No ongoing or active infection
- No other uncontrolled concurrent illness that would preclude study entry
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Phase I:
- Prior chemotherapy allowed
Phase II:
- No prior chemotherapy for metastatic disease
- Prior adjuvant therapy allowed if disease progresses during adjuvant therapy
- No prior oxaliplatin
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy and recovered
Surgery
- See Disease Characteristics
- More than 3 weeks since prior major surgery and recovered
- No prior surgical procedures affecting absorption
Other
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies (commercial or investigational)
- No concurrent combination antiretroviral therapy for HIV-positive patients
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Маскировка: Нет (открытая этикетка)
Соавторы и исследователи
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания пищеварительной системы
- Новообразования
- Новообразования по локализации
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Желудочно-кишечные заболевания
- Заболевания толстой кишки
- Кишечные заболевания
- Новообразования кишечника
- Заболевания прямой кишки
- Колоректальные новообразования
- Физиологические эффекты лекарств
- Молекулярные механизмы фармакологического действия
- Ингибиторы ферментов
- Антиметаболиты, Противоопухолевые
- Антиметаболиты
- Противоопухолевые агенты
- Иммунодепрессанты
- Иммунологические факторы
- Защитные агенты
- Микроэлементы
- Ингибиторы протеинкиназы
- Витамины
- Кальций-регулирующие гормоны и агенты
- Противоядия
- Комплекс витаминов группы В
- Эрлотиниб гидрохлорид
- Фторурацил
- Оксалиплатин
- Лейковорин
- Кальций
- Леволейковорин
Другие идентификационные номера исследования
- CDR0000257808
- MSKCC-02039
- NCI-5371
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования фторурацил
-
Massachusetts General HospitalStand Up To CancerРекрутингМетастатический рак толстой кишки | Рак толстой кишки III стадииСоединенные Штаты