NCT00058253已完成1 期
A Phase I Study of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG, NSC# 330507) in Combination With Docetaxel in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose determined by dose-limiting toxicities assessed using the NCI Common Toxicity Criteria (CTC) version 2.0
研究概览
简要总结
This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as docetaxel and 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
详细描述
OBJECTIVES:
I. Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) administered with docetaxel in patients with progressive metastatic prostate cancer or other progressive metastatic or unresectable solid tumors.
II. Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Patients are assigned to 1 of 2 treatment groups.
Group 1: Patients receive docetaxel IV over 1 hour and 17-AAG IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed metastatic or unresectable malignancy for which standard curative or palliative therapy does not exist or is no longer effective
- •Progressive disease manifested by the following parameters
- •For prostate cancer:
- •Must have castrate, metastatic disease defined by disease progression after surgical castration or treatment with a gonadotropin-releasing hormone (GnRH) analog (testosterone level less than 50 ng/mL)
- •Patients who have not undergone surgical orchiectomy should continue on medical therapies to maintain castrate levels of testosterone
- •Progressive metastatic disease on imaging studies (bone scan, CT scan, or MRI) OR metastatic disease and a rising prostate-specific antigen (PSA)
- •Biochemical progression indicated by at least 3 rising PSA values (obtained at least 1 week apart) from a baseline OR 2 rising PSA values (more than 1 month apart), where the percentage increase over the range of values is at least 25%
- •Patients who have received an antiandrogen as part of first-line hormonal therapy must have shown progression of disease off of the antiandrogen prior to study enrollment
- •For other solid tumors:
- •Development of new lesions or an increase in pre-existing lesions by bone scintigraphy, CT scan, MRI, positron emission tomography, or physical examination
- •Patients whose sole criterion for progression is an increase in a biochemical marker (e.g., carcinoembryonic antigen or CA 15-3) or an increase in symptoms are not eligible
- •Patients with metastatic disease must not be progressing to the extent as to require palliative treatment within 4 weeks of study entry
- •No active brain metastases
- •Performance status - Karnofsky 70-100%
- •More than 6 months
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT < 1.5 times ULN
- •PT ≤ 1.1 times ULN
- •Creatinine no greater than 1.4 mg/dL or within ULN
- •Creatinine clearance greater than 55 mL/min
- •No prior history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)
- •No dyspnea ≥ grade 2 at rest on room air
- •No requirement for supplementary oxygen therapy or oxygen saturations ≤ 88%
- •No clinically significant pulmonary comorbidities that require medication (e.g., severe chronic obstructive pulmonary disease that could predispose patient to pulmonary toxicity)
- •QTc ≤ 450 msec for male patients (470 for female patients)
- •LVEF > 40% by echocardiogram or MUGA
- •Echocardiogram or MUGA required for patients with any of the following:
- •Myocardial infarction > 1 year ago
- •NYHA class I or II CHF
- •Atrial fibrillation
- •Right or left bundle branch block by EKG
- •No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- •No myocardial infarction within the past year
- •No active ischemic heart disease within the past year
- •No New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
- •No poorly controlled angina
- •No uncontrolled dysrhythmia
- •No congenital long QT syndrome
- •No left bundle branch block
- •No other significant cardiac disease
- •No prior history of cardiac toxicity after receiving anthracyclines such as doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of severe hypersensitivity reaction to paclitaxel, docetaxel, or polysorbate 80
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- 另有 45 项未显示
排除标准
- 未提供
研究组 & 干预措施
Group I
Experimental
Patients receive docetaxel IV over 1 hour and 17-AAG IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: tanespimycin (Drug)
Group I
Experimental
Patients receive docetaxel IV over 1 hour and 17-AAG IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: docetaxel (Drug)
Group II
Experimental
Patients receive docetaxel IV over 30 minutes and 17-AAG as in group 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: tanespimycin (Drug)
Group II
Experimental
Patients receive docetaxel IV over 30 minutes and 17-AAG as in group 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: docetaxel (Drug)
结局指标
主要结局
Maximum tolerated dose determined by dose-limiting toxicities assessed using the NCI Common Toxicity Criteria (CTC) version 2.0
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (1)
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