NCT00584012终止1 期
A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer
Susan L Roeder1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2004年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence of Dose-limiting Toxicities (DLTs)
研究概览
简要总结
This purpose of this study is to evaluate the use of two medications, docetaxel and lovastatin to determine the highest dose of lovastatin and docetaxel that can be given safely as well as the safety of combining the two drugs and the effect on the subject's tumor. Subjects can have any cancer.
详细描述
The primary objective of this study is to determine the maximum tolerated dose (MTD) of lovastatin and docetaxel in patients with various different cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years of age
- •Performance Status (ECOG) <2
- •Peripheral Neuropathy < grade I
- •Signed Informed consent
- •Hematologic-Inclusion Absolute neutrophil count > 1,500/mm3 Hemoglobin > 8.0 g/dl Platelet count > 100,000/mm
- •Hepatic-Inclusion Total Bilirubin must be within normal limits.
- •Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN.
- •Patients may have received prior chemotherapy including treatment with the following agents: anthracycline, platinum, vinorelbine, or other Vinca alkaloids. The patient must have recovered from the side effects of the prior treatment including prior drug-induced peripheral neuropathy.
- •Patients who have received prior taxane therapy will be eligible. (However, patients who have progressed within 6 months of receiving docetaxel will be excluded.)
- •A minimum of 28 days must have elapsed from the completion of any prior chemotherapy or radiation treatment.
- •Patients who are currently receiving bisphosphonates for bone disease will be allowed to enter the trial, however their bone lesions will not be considered assessable for response, but will be assessable for progression.
- •Initiation of bisphosphonate treatment during the trial will be discouraged but allowed in the absence of progressive disease. If bisphosphonates are initiated, then bone lesions will be assessed for progression only.
排除标准
- •Other serious illnesses, which would limit survival to <2 months, or a psychiatric condition, which would prevent compliance with treatment or informed consent.
- •ECOG Performance Status >2
- •Anticipated survival < 2 months
- •Uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection, which in the opinion of the treating physician would make this protocol treatment unreasonably hazardous for the patient.
- •Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse within one year.
- •Patients who have received any investigational agent within the prior 4 weeks.
- •Age < 18 as there is no safety data for lovastatin in this age range.
- •Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate
- •Patients who have received anticancer endocrine therapy within 4 weeks prior to registration are not eligible.
- •Patients currently on daily statin therapy will also be excluded.
- •Patients who have progressed within 6 months of receiving docetaxel are not eligible.
- •Treatment with the anti-emetic Aprepitant is not allowed.
- •Patients who are currently receiving , or have received Herceptin therapy within 4 weeks prior to registration are not eligible.
- •Pregnant and/or Nursing. Patients must not be pregnant or nursing at the time of enrollment nor while under the treatment of this protocol. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.
研究组 & 干预措施
Dose Esclation
Experimental
Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.
干预措施: Lovastatin (Drug)
Dose Esclation
Experimental
Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Incidence of Dose-limiting Toxicities (DLTs)
时间窗: 27 weeks
To determine the maximum tolerated doses (MTD) of lovastatin and docetaxel in patients with various cancers having solid tumors.
次要结局
未报告次要终点
研究者
Susan L Roeder
Physician
University of Iowa
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation DisordersChronic Subdural HematomaNCT02192320Oriental Neurosurgery Evidence-Based-Study Team60
终止
2 期
Docetaxel and Liposomal Doxorubicin Chemotherapy With Enoxaparin in Patients With Advanced Pancreatic CancerPancreatic CancerNCT00426127University of Iowa2
Unknown
不适用
A Study of Docetaxel and Lobaplatin Versus Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian CancerRecurrent Ovarian CancerNCT01851746Wuhan University200
终止
1 期
Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Refractory or Relapsed AMLAcute Myeloid LeukemiaNCT00583102University of Iowa23
已完成
1 期
Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate CancerMetastatic Prostate CancerNCT00439270Bristol-Myers Squibb49