Immunochemotherapy for Metastatic Renal Cell Carcinoma
Клучни зборови
Апстракт
Опис
This is a phase II study, non-randomized in patients with metastatic renal cell carcinoma. The treatment will include: Proleukin (produced by Chiron and supplied by Megapharm Israel Ltd), Roferon A and Xeloda (produced by Roche) and VBL. The treatment will be given in 8-week courses with an interval of two weeks of rest in which the response (on D63) and toxicity will be assessed.
45 patients with MRCC will be entered into this study during a 18-month period. All patients must meet all inclusion and exclusion criteria. All data of each participating patient, including medical history, disease characteristics, laboratory and imaging tests, response and toxicity to treatment will be entered into the specific form before, during, after each treatment course and during follow up.
Patients will be followed up for survival status and disease status every 6 months until last visit or death.
Treatment Schedule:
Proleukin S.C. 10X106 IU/m2 three times a week (Sun, Tue, Thu), weeks 1 - 4 Roferon A S.C. 6 X 106 IU/m2 once a week (Wed), weeks 1 - 4 Roferon A S.C. 3 X 106 IU/m2 three times a week, weeks 5 - 8 Xeloda Oral 1,000 mg/m2 twice a day, weeks 5, 6 Vinblastine I.V. 4mg/m2, Day 1, weeks 5 &
Датуми
Последен пат проверено: | 08/31/2005 |
Прво доставено: | 09/25/2005 |
Поднесено е проценето запишување: | 09/25/2005 |
Прво објавено: | 09/26/2005 |
Последното ажурирање е доставено: | 12/30/2005 |
Последно ажурирање објавено: | 01/03/2006 |
Крај на датумот на започнување на студијата: | 11/30/2003 |
Проценет датум на завршување на студијата: | 08/31/2005 |
Состојба или болест
Интервенција / третман
Drug: Capecitabine (Xeloda)
Фаза
Критериуми за подобност
Возраст подобни за студии | 18 Years До 18 Years |
Полови квалификувани за студии | All |
Прифаќа здрави волонтери | Да |
Критериуми | Inclusion Criteria: - Inclusion Criteria; Patients with the following criteria will be included in this study - Pathological (histology or cytology) diagnosis of renal cell carcinoma - Clinical evidence of metastatic disease - Performance status 0 - 2 (European Cooperative Oncology Group Score) - Nephrectomy before starting treatment - Normal cardiac function (left ventricular ejection fraction >45%). - Normal blood counts: WBC >3,000/ml3, Hb >10gr%, Platelets >100,000/ml3 - Normal kidney function: Creatinine <1.3 mg/dl - Age 18 years - Patient's written consent (on informed consent form) Exclusion Criteria: - Life expectancy less than 3 months - Brain metastases - Ischemic heart disease - active - Prior immunochemotherapy - Performance status 3 or more (European Cooperative Oncology Group Score) - Schizophrenia - Active liver disease |
Исход
Мерки на примарниот исход
1. Objective response [undefined]
Секундарни мерки на исходот
1. Toxicity [undefined]