NCT00309894已完成2 期
Phase II Trial to Assess the Activity of Ketoconazole Plus GM-CSF in Patients With Prostate Cancer Progressive After Androgen Deprivation
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Time to progression
研究概览
简要总结
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. GM-CSF may help ketoconazole work better by making tumor cells more sensitive to the drug. Giving ketoconazole together with hydrocortisone and GM-CSF may be an effective treatment for prostate cancer.
PURPOSE: This phase II trial is studying how well giving ketoconazole together with hydrocortisone and GM-CSF works in treating patients with progressive prostate cancer after hormone therapy.
详细描述
OBJECTIVES:
Primary
- Evaluate the effect of ketoconazole, hydrocortisone, and sargramostim (GM-CSF) on time to clinical progression in patients with prostate cancer that has progressed on primary hormonal therapy.
Secondary
- Evaluate the objective response frequency in patients treated with this regimen.
- Investigate the safety of this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Progressive disease after androgen deprivation AND meets 1 of the following criteria:
- •Measurable disease
- •Measurable lesions ≥ 10 mm with spiral CT
- •Up to 5 lesions per organ and 10 lesions total should be identified as target lesions
- •No measurable disease
- •Patients with prostate-specific antigen (PSA)-only disease must have an elevated PSA
- •PSA evidence for progressive disease consists of a PSA level of ≥ 5 ng/mL that has risen on ≥ 2 successive occasions, ≥ 2 weeks apart
- •Patients with a positive bone scan must also have an elevated PSA
- •Patients who received prior antiandrogen as a part of primary androgen ablation therapy must demonstrate disease progression after discontinuation of the antiandrogen
- •Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values obtained ≥ 2 weeks apart, or documented osseous or soft tissue progression
- •Patients receiving flutamide must have had ≥ 1 of the PSA values obtained ≥ 4 weeks after flutamide discontinuation
- •Patients receiving bicalutamide or nilutamide must have had ≥ 1 of the PSA values obtained ≥ 6 weeks after antiandrogen discontinuation
- •Testosterone < 50 ng/dL
- •PSA ≥ 5 ng/mL
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 60-100%
- •No serious intercurrent infections or nonmalignant uncontrolled medical illnesses
- •No psychiatric illnesses OR social situations that would limit compliance
- •No active or uncontrolled autoimmune disease
- •ALT and AST normal
- •Bilirubin normal
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine ≤ 1.5 times upper limit or normal (ULN)
- •Hemoglobin ≥ 8 g/dL
- •No other currently active malignancy except for nonmelanoma skin cancer
- •No currently active malignancy defined as therapy completed with ≤ 30% risk of relapse
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Patients must continue primary androgen deprivation therapy with a luteinizing-hormone releasing-hormone (LHRH) analogue if they have not undergone orchiectomy
- •No prior systemic chemotherapy for prostate cancer
- •All other systemic chemotherapy must have been completed ≥ 2 years prior to study
- •No other concurrent chemotherapy, immunotherapy, or radiotherapy
- •Major surgery or radiation therapy completed ≥ 4 weeks prior to study
- •No other concurrent corticosteroids, including routine use antiemetics
- •No prior ketoconazole, aminoglutethimide, or corticosteroids for treatment of progressive prostate cancer
- •No prior immunotherapy (e.g., vaccines or sargramostim GM-CSF)
- •Patients receiving any other hormonal therapy (e.g., megestrol, finasteride, herbal product known to decrease PSA levels [e.g., saw palmetto or PC-SPES], or any systemic corticosteroid) must discontinue the agent ≥ 4 weeks prior to enrollment and progressive disease must be documented after discontinuation
- •No initiation of bisphosphonate therapy within 1 month prior to starting study therapy
- •Patients on stable doses that show tumor progression are allowed to continue bisphosphonate
- •No concurrent supplements or complementary medicines/botanicals, except any combination of the following:
- •Conventional multivitamin supplements
- •Soy supplements
- •Vitamin E
- •At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium)
- •No other concurrent investigational or commercial anticancer agents or therapies
排除标准
- 未提供
结局指标
主要结局
Time to progression
次要结局
- Frequency of grades 3-4 toxicity
- Response rate as measured by prostate-specific antigen and objective parameters
- Pattern of immune response as measured by immunohistochemistry
研究者
研究点 (2)
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