NCT00416429已完成3 期
Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis [PERCY QUATTRO]
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 456
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Medroxyprogesterone may help shrink or slow the growth of kidney cancer. Interferon may interfere with the growth of tumor cells. Aldesleukin may stimulate white blood cells to kill tumor cells. It is not yet known whether giving medroxyprogesterone, interferon, or aldesleukin alone is more effective than giving interferon together with aldesleukin in treating kidney cancer.
PURPOSE: This randomized phase III trial is studying medroxyprogesterone, interferon, or aldesleukin to see how well they work when given alone compared to interferon combined with aldesleukin in treating patients with metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the overall survival of patients with metastatic renal cell adenocarcinoma treated with medroxyprogesterone vs recombinant interferon alfa-2a and/or aldesleukin.
Secondary
- Determine the objective response rate (complete and partial) of patients treated with these regimens.
- Determine the progression-free survival of patients treated with these regimens.
- Determine the toxicity of these regimens in these patients.
- Evaluate the quality of life of patients before and after induction treatment with these regimens (week 10).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic renal cell adenocarcinoma, meeting 1 of the following criteria:
- •More than 1 metastatic site and good performance status (Karnofsky score 80-100%)
- •Sole metastatic site with Karnofsky score = 80%
- •Karnofsky 90% or 100% not eligible
- •No combination of several metastatic sites and liver metastases and a time interval from primary tumor to metastases of < 1 year
- •Nonmeasurable disease and/or few numbers of lesions must be confirmed histologically and as progressive disease
- •The following metastases are allowed:
- •Lung with or without mediastinum lymph nodes
- •Pleura (solid or liquid with positive cytology)
- •Thoracic lymph nodes
- •Abdominal lymph nodes
- •Superficial lymph nodes
- •Subcutaneous skin/tissue
- •Contralateral kidney
- •Nephrectomy site
- •Other organs
- •Prior metastases allowed provided the following criteria are met:
- •Evidence of progressive disease within the past 3 months
- •Metastases evaluated by noninvasive methods
- •No evidence of active brain metastases
- •Prior brain metastases allowed provided all of the following criteria are met:
- •Disease is stable
- •Reductive therapy (surgery or radiotherapy) completed at least 3 weeks prior to study entry
- •Metastases have not progressed (confirmed by CT scan or MRI)
- •No concurrent corticosteroids required
- •PATIENT CHARACTERISTICS:
- •See Disease Characteristics
- •Creatinine < 1.8 mg/dL
- •Hematocrit ≥ 30%
- •WBC ≥ 4,000/mm^3
- •Platelet count ≥ 120,000/mm^3
- •Bilirubin normal
- •LVEF ≥ 50%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No HIV positivity
- •No severe infection requiring antibiotic therapy
- •No chronic hepatitis
- •No severe lung, liver or kidney condition that would preclude study treatment
- •No hepatitis B surface antigen positivity
- •No severe neuropsychiatric condition or epilepsy
- •No serious thromboembolitic disorder
- •No severe cardiac dysfunction (e.g., congestive heart failure, uncontrolled hypertension, serious arrhythmia, or coronary disease)
- •No other prior or concurrent primary malignancies except for basal cell skin cancer or carcinoma in situ of the cervix
- •No geographical, psychological, or familial condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •More than 6 weeks since prior wide-field radiotherapy
- •No prior systemic chemotherapy
- 另有 7 项未显示
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Objective response rate (complete and partial)
- Progression-free survival
- Toxicity
- Quality of life in week 10
研究者
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