A Phase I Trial of Docetaxel and Sirolimus in Patients With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose(MTDs) for Docetaxel - Sirolimus
研究概览
简要总结
The goal of this clinical research study to find the highest tolerated dose of the combination of Taxotere (docetaxel) and Rapamycin (sirolimus) when given to patients with advanced cancer.
Researchers also want to find highest tolerated dose of the combination of docetaxel, sirolimus, and prednisone when given to patients with advanced prostate cancer. The safety of both drug combinations will also be studied.
详细描述
The Study Drugs:
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in tumor tissue as well.
Sirolimus is designed to block a protein called mammalian target of rapamycin (mTOR) inside the cancer cell.
Prednisone is a corticosteroid that is similar to a natural hormone made by your body. Prednisone is often given in combination with chemotherapy to treat cancer.
Study Groups:
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
- •Patients must be at least 5 half-lives or three weeks, whichever is shorter, from their previous targeted or biologic therapy; patients must be at least three weeks beyond previous cytotoxic therapy. In addition, patients must be >/= 3 weeks beyond previous therapeutic radiation or major surgery. Patients may have received palliative localized radiation immediately before or during treatment providing radiation is not delivered only to the site of disease being treated under this protocol. Terminal phase half life of docetaxel is 11.1 hours; sirolimus, 14.5 hours.
- •cont'd from criterion #2 Previous mTOR inhibitor (everolimus, temsirolimus, and sirolimus) and taxane (including paclitaxel, abraxane/ABI-007, and docetaxel) therapy is permitted.
- •Eastern Cooperative Oncology Group (ECOG) performance status </= 3
- •Patients must have normal organ and marrow function defined as:absolute neutrophil count >/= 1,000/mL; platelets >/=50,000/mL; creatinine </= 2 x upper limit of normal (ULN); total bilirubin </= 3x ULN; ALT(SGPT) </= 3 x ULN; cholesterol </= 350 mg/dL; triglycerides </= 400 mg/dL.
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
- •Patients must be able to understand and be willing to sign a written informed consent document.
- •Patients already on gonadotropin-releasing hormone (GnRH) agonist therapy (eg goserelin acetate, leuprolide acetate) for metastatic, castrate-resistant prostate cancer for three months prior to entry into this study may be continued on this intervention while enrolled in this protocol. Patients on somatostatin analogues (eg octreotide) for symptom control for three months prior to entry into this study may be continued on this intervention while enrolled in this protocol.
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, and need for ventilatory support.
- •Pregnant or lactating women.
- •History of hypersensitivity to docetaxel or any component of the formulation.
- •History of hypersensitivity to sirolimus or any component of the formulation
- •Patients maintained on medications that are strong inducers or inhibitors of CYP3A4 should have these medications discontinued prior to entry on study unless cessation of such medications would be detrimental to patient's health.
- •Patients unwilling or unable to sign informed consent document.
研究组 & 干预措施
Docetaxel + Sirolimus
Starting doses of Docetaxel 30 mg/m^2 IV every 3 weeks + Sirolimus 1 mg daily
干预措施: Docetaxel (Taxotere) (Drug)
Docetaxel + Sirolimus
Starting doses of Docetaxel 30 mg/m^2 IV every 3 weeks + Sirolimus 1 mg daily
干预措施: Sirolimus (Rapamycin) (Drug)
Docetaxel + Sirolimus
Starting doses of Docetaxel 30 mg/m^2 IV every 3 weeks + Sirolimus 1 mg daily
干预措施: Prednisone (Drug)
结局指标
主要结局
Maximum Tolerated Dose(MTDs) for Docetaxel - Sirolimus
时间窗: Every week for first 3 weeks then every 3 weeks
次要结局
未报告次要终点