- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00074204
Gemcitabine and Carboplatin Followed By Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase III Study of Delayed vs. Immediate Second-Line Therapy With Docetaxel After Gemcitabine + Carboplatin in Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which treatment regimen is more effective for stage IIIB or stage IV non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine and carboplatin followed immediately by docetaxel with that of giving delayed docetaxel in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
OBJECTIVES:
Primary
- Compare the overall survival of patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine and carboplatin followed by immediate vs delayed docetaxel.
Secondary
- Compare the response rate and time to progression in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance status (0 or 1 vs 2).
All patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with stable or responding disease proceed to docetaxel therapy. Patients are randomized to 1 of 2 treatment arms.
- Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
- Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life (QOL) is assessed at baseline, at restaging (after completion of gemcitabine and carboplatin), before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment.
NOTE: *For patients randomized to delayed docetaxel, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Ohio
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Cleveland, Ohio, Соединенные Штаты, 44106-5065
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive 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 or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB with pleural effusion OR stage IV disease
- Recurrent disease after primary treatment with radiotherapy or surgery allowed
Measurable disease or nonmeasurable disease
- Measurable disease, defined as at least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
Nonmeasurable disease, defined as all other lesions, including small lesions (longest diameter less than 20 mm by conventional techniques OR less than 10 mm by spiral CT scan) or any of the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Cystic lesions
- Abdominal masses not confirmed and followed by imaging techniques
No symptomatic CNS metastases
- Treated, stable CNS metastases allowed provided patient is not receiving radiotherapy or corticosteroids
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 3.0 times upper limit of normal (ULN) (less than 5.0 times ULN for patients with documented benign disease)
- Alkaline phosphatase less than 3.0 times ULN (for patients with documented benign disease)
Renal
- Creatinine no greater than 1.5 mg/dL
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after study participation
- No active and ongoing infection
- No concurrent serious systemic disorder that would preclude study participation
No other primary malignancy within the past 5 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or T1 vocal cord cancer in remission
- Other prior cancers unlikely to affect survival for the next 3 years (e.g., low-grade early stage prostate cancer) are allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No prior chemotherapy for NSCLC, including neoadjuvant and adjuvant therapy
- No other concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- No concurrent antitumor hormonal therapy (excluding contraceptives and replacement steroids)
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- Prior radiotherapy to less than 25% of bone marrow allowed provided the irradiated area is not the only site of measurable disease
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
Other
- At least 3 weeks since prior therapy for cancer
- More than 4 weeks since prior investigational agents
- No other concurrent experimental medications
- No other concurrent therapy for cancer
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Immediate Docetaxel
Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
|
Carboplatin IV over 30-60 minutes on day 1.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1. Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
|
Активный компаратор: Delayed Docetaxel
Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.
|
Carboplatin IV over 30-60 minutes on day 1.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1. Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Survival
Временное ограничение: Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
|
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Response rate (partial and complete response)
Временное ограничение: Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
|
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
|
|
Time to progression
Временное ограничение: treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression.
|
treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression.
|
|
Toxicity as measured by NCI CTC
Временное ограничение: at baseline and at the end of each course not at day 8
|
at baseline and at the end of each course not at day 8
|
|
Quality of life as measured by the lung cancer symptom scale
Временное ограничение: At baseline, at restaging, before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment. Arm II, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel.
|
At baseline, at restaging, before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment. Arm II, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel.
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Nathan Levitan, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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 (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания дыхательных путей
- Новообразования
- Легочные заболевания
- Новообразования по локализации
- Новообразования дыхательных путей
- Грудные новообразования
- Рак, Бронхогенный
- Бронхиальные новообразования
- Новообразования легких
- Карцинома немелкоклеточного легкого
- Физиологические эффекты лекарств
- Молекулярные механизмы фармакологического действия
- Противоинфекционные агенты
- Противовирусные агенты
- Ингибиторы ферментов
- Антиметаболиты, Противоопухолевые
- Антиметаболиты
- Противоопухолевые агенты
- Иммунодепрессанты
- Иммунологические факторы
- Модуляторы тубулина
- Антимитотические агенты
- Модуляторы митоза
- Гемцитабин
- Доцетаксел
- Карбоплатин
Другие идентификационные номера исследования
- LILY1503
- P30CA043703 (Грант/контракт NIH США)
- CASE-CWRU-LILY-1503 (Другой идентификатор: Case Comprehensive Cancer Center)
- LILLY-B9E-US-S245
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. .