Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function
PHASE I STUDY OF TAXOTERE IN PATIENTS WITH ADVANCED MALIGNANCIES AND VARYING DEGREES OF LIVER DYSFUNCTION
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of docetaxel in treating patients with advanced solid tumors that have not responded to standard therapy or for which there is no effective therapy.
研究概览
详细说明
OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel in patients with advanced solid tumors and varying degrees of liver dysfunction. II. Determine the effects of liver dysfunction in these patients on the plasma pharmacokinetics and pharmacodynamics of this therapy. III. Determine the utility of indocyanine green clearance and lidocaine metabolism as indicators of hepatic elimination of docetaxel in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild vs moderate vs severe). Patients receive docetaxel IV over 1 hour. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR. Within each abnormal liver function stratum, cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Within each abnormal liver function stratum, more than 6 patients are treated at the MTD, if possible. Patients in the normal liver function stratum are included as control patients and are followed for toxicity, but do not undergo dose escalation. Patients are followed for survival.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18 months.
研究类型
阶段
- 阶段1
联系人和位置
学习地点
-
-
California
-
Duarte、California、美国、91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
-
Los Angeles、California、美国、90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
-
Sacramento、California、美国、95817
- University of California Davis Cancer Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS: Histologically proven solid tumor that is refractory to standard therapy or for which no standard therapy exists Eligible tumors, include, but are not limited to, the following: Breast Ovarian Head and neck Non-small cell lung cancer Abnormal liver function Control patients with normal liver function are enrolled Brain metastases allowed if controlled by radiotherapy or surgery and neurologic status currently stable Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Not specified Menopausal status: Not specified Performance status: Karnofsky 50-100% Life expectancy: At least 1 month Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL OR Hematocrit at least 35% Hepatic: See Disease Characteristics No active acute hepatitis Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No concurrent cardiovascular disease that is poorly controlled with currently available treatment or of such severity as to preclude study Pulmonary: No concurrent pulmonary disease that is poorly controlled with currently available treatment or of such severity as to preclude study Other: No other concurrent illness (e.g., CNS disease) that is poorly controlled with currently available treatment or of such severity as to preclude study No severe infection requiring treatment Not pregnant Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 25% of bone marrow Surgery: See Disease Characteristics Recovered from major surgery
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
合作者和调查者
调查人员
- 学习椅:James H. Doroshow, MD、City of Hope Comprehensive Cancer Center
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
- IV期乳腺癌
- IIIA期乳腺癌
- 复发性乳腺癌
- IIIB期乳腺癌
- 复发性非小细胞肺癌
- IIIA期非小细胞肺癌
- IIIB期非小细胞肺癌
- IV期非小细胞肺癌
- 未指定的成人实体瘤,具体方案
- 复发性转移性鳞状颈部癌伴隐匿性原发灶
- III期唇和口腔鳞状细胞癌
- III期唇基底细胞癌
- III期口腔疣状癌
- III期口腔粘液表皮样癌
- III期口腔腺样囊性癌
- IV期唇和口腔鳞状细胞癌
- IV期唇基底细胞癌
- IV期口腔疣状癌
- IV期口腔粘液表皮样癌
- IV期口腔腺样囊性癌
- 唇和口腔复发性鳞状细胞癌
- 唇部复发性基底细胞癌
- 复发性口腔疣状癌
- 复发性口腔黏液表皮样癌
- 复发性口腔腺样囊性癌
- III期口咽鳞状细胞癌
- III期口咽淋巴上皮瘤
- IV期口咽鳞状细胞癌
- IV期口咽淋巴上皮瘤
- 复发性口咽鳞状细胞癌
- 复发性口咽淋巴上皮瘤
- III期鼻咽鳞状细胞癌
- III期鼻咽淋巴上皮瘤
- IV期鼻咽鳞状细胞癌
- IV期鼻咽淋巴上皮瘤
- 复发性鼻咽鳞状细胞癌
- 复发性鼻咽淋巴上皮瘤
- 下咽部 III 期鳞状细胞癌
- 下咽部鳞状细胞癌 IV 期
- 下咽部复发性鳞状细胞癌
- III期喉鳞状细胞癌
- III期喉疣状癌
- IV期喉鳞状细胞癌
- IV期喉疣状癌
- 复发性喉癌
- 复发性喉癌
- III期鼻窦和鼻腔鳞状细胞癌
- III 期鼻窦和鼻腔中线致死性肉芽肿
- III期鼻窦和鼻腔感觉神经母细胞瘤
- IV 期鼻窦和鼻腔鳞状细胞癌
- IV 期鼻窦和鼻腔中线致死性肉芽肿
- IV 期鼻窦和鼻腔感觉神经母细胞瘤
- 鼻窦和鼻腔复发性鳞状细胞癌
- 鼻窦和鼻腔复发性中线致死性肉芽肿
- 鼻窦鼻腔复发性感觉神经母细胞瘤
- III期卵巢上皮癌
- IV期卵巢上皮癌
- 复发性卵巢上皮癌
- 卵巢肉瘤
- 交界性卵巢表面上皮间质瘤
- 卵巢间质癌
- 复发性卵巢生殖细胞瘤
- III期卵巢生殖细胞瘤
- IV期卵巢生殖细胞瘤
- 鼻窦鼻腔复发性内翻性乳头状瘤
- 鼻窦鼻腔内翻性乳头状瘤Ⅲ期
- IV期鼻窦鼻腔内翻性乳头状瘤
- IV期鼻咽癌
其他相关的 MeSH 术语
其他研究编号
- CDR0000065241
- P30CA033572 (美国 NIH 拨款/合同)
- U01CA062505 (美国 NIH 拨款/合同)
- CHNMC-PHI-08
- CHNMC-IRB-96118
- LAC-USC-PHI-08
- NCI-T96-0028H
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.