NCT00293371终止1 期
A Phase I/II Study of Docetaxel/Prednisone and PTK 787/ZK 222584 in Previously Untreated Metastatic Hormone Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Time to prostate-specific antigen (PSA) and objective progression
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving vatalanib together with docetaxel and prednisone may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vatalanib when given together with docetaxel and prednisone and to see how well they work in treating patients with advanced prostate cancer.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicities and maximum tolerated dose of vatalanib when used in combination with docetaxel and prednisone in patients with chemotherapy-naive, metastatic, hormone-refractory prostate cancer. (phase I)
Secondary
- Determine alterations in pharmacokinetics of docetaxel and vatalanib in these patients. (phase I)
- Determine the clinical efficacy of this regimen as measured by declines in prostate-specific antigen, measurable disease response, time to progression, and overall survival. (phase II)
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically documented adenocarcinoma of the prostate
- •Progressive, systemic (metastatic) disease despite castrate levels of testosterone due to orchiectomy or luteinizing-hormone releasing hormone (LHRH) agonist, meeting 1 of the following criteria:
- •Measurable disease, defined as any lesion that can be accurately measured in at least 1 dimension ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan or MRI
- •Nonmeasurable disease with PSA ≥ 5 ng/mL
- •Bone lesions
- •Pleural or pericardial effusions, ascites
- •CNS lesions, leptomeningeal disease
- •Irradiated lesions, unless progression documented after radiotherapy
- •No PSA ≥ 5 ng/mL as only evidence of disease
- •PSA evidence for progressive prostate cancer consists of a PSA level ≥ 5 ng/mL that has risen on ≥ 2 successive occasions, ≥ 2 weeks apart
- •Castrate levels of testosterone (< 50 ng/dL) must be maintained
- •If no prior orchiectomy, patients must remain on testicular androgen suppression (e.g., with an LHRH analogue)
- •Patients receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression after discontinuation of antiandrogen
- •Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression
- •For patients receiving flutamide or megestrol acetate, at least 1 of the PSA values must be obtained 4 weeks or more after flutamide/megestrol acetate discontinuation
- •For patients receiving bicalutamide or nilutamide, at least 1 of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation
- •If improvement after antiandrogen withdrawal is noted, disease progression must be established
- •No pleural effusion or ascites that causes respiratory compromise ( ≥ grade 2 dyspnea)
- •No history of CNS disease, including primary brain tumor, seizures, or carcinomatous meningitis
- •PATIENT CHARACTERISTICS:
- •Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
- •Karnofsky performance status ≥ 60%
- •Life expectancy > 12 weeks
- •Granulocyte count > 1,500/mm^3
- •Platelet count > 75,000/mm^3
- •Hemoglobin > 8.0 g/dL
- •Creatinine < 1.5 times upper limit of normal (ULN)
- •Bilirubin < 1.5 times ULN
- •SGOT/SGPT < 1.5 times ULN
- •Urinalysis ≤ 1+ proteinuria based on dipstick reading OR 2+ proteinuria on dipstick reading AND total urinary protein ≤ 3,500 mg on 24 hour urine collection and creatinine clearance ≥ 50 mL/min on a 24-hour urine collection
- •No impairment of gastrointestinal (GI) function or GI disease that may affect or alter absorption of vatalanib (i.e., malabsorption syndromes)
- •No myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (New York Heart Association class III or IV), or uncontrolled cardiac arrhythmia
- •No pre-existing grade 3 or 4 clinical peripheral neuropathy
- •No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •No deep vein thrombosis or pulmonary embolus within the past year
- •No poorly controlled diabetes (fasting blood glucose > 250) despite optimization of medical therapy
- •No labile or poorly controlled hypertension (systolic blood pressure > 160 mm Hg, diastolic blood pressure > 90 mm Hg) despite maximal management with anti-hypertensives
- •No serious uncontrolled, concurrent medical illness, including ongoing or active infection
- •Patients on Suppressive antibiotic therapy for chronic urinary tract infection are eligible
- •No psychiatric illness or social situation that would limit compliance with treatment
- •No "currently active" second malignancy other than nonmelanoma skin cancers
- •Not considered "currently active" if competed therapy and at < 30% risk of relapse
- •No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No grapefruit or grapefruit juice during study treatment
- •No history of gastrectomy/small bowel resection
- •At least 4 weeks since prior hormonal therapy, including ketoconazole, aminoglutethimide, systemic steroids (any dose), and megestrol acetate (any dose)
- •At least 4 weeks since prior drug or herbal product known to decrease PSA levels (e.g., finasteride, saw palmetto, or PC-SPES)
- 另有 17 项未显示
排除标准
- 未提供
结局指标
主要结局
Time to prostate-specific antigen (PSA) and objective progression
Response rate (PSA and objective)
Toxicity
次要结局
未报告次要终点
研究者
研究点 (1)
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