Phase I Study of Bi-weekly Taxol and Definitive Radiation in Androgen Ablated Locally Advanced Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Number of participants with qualitative and quantitative toxicities
研究概览
简要总结
The purpose of this study is to determine if the combination therapy of Hormone, Paclitaxel and Radiation therapy are effective in treatment of locally advanced prostate cancer
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Any one or more of the following characteristics will qualify patient with T2/T3 prostate cancer for eligibility to current study:
- •Biopsy proven prostate cancer with Gleason score > 7
- •Pathologic staging TXN1 (on MRI or CT)
- •Prostate-specific antigen (PSA) > 10 ng/ml done within a month prior to study entry (the day of first hormonal ablation) and > 10 days after prostate biopsy.
- •In addition patients must also have:
- •Performance status < 2
- •Hemoglobin > 11 grams per deciliter (g/dL), White blood cell (WBC) > 4000 and platelet count > 100.000/l
- •No evidence of other synchronous primary. Prior malignancies does not exclude if the patient is disease free > 5 years.
- •Prior or concurrent basal cell or non-invasive squamous carcinoma of the skin is eligible and
- •Received hormone therapy with any of the following combination for less than 3 months
- •Lupron / Flutamide
- •Zoladex/ Flutamide
- •Lupron/ Casodex
- •Zoladex/ Casodex
排除标准
- •Clinical stage T1N0, PSA < 10, and Gleason score less than
- •Evidence of distant metastasis
- •Previous surgery for prostate cancer (radical prostatectomy).
- •Current treatment with ketoconazole, cimetidine or hormone therapy for more than 3 months prior to inclusion in the protocol for prostate cancer
- •Major medical or psychiatric illness, which in the investigator's opinion may prevent completion of the study and interfere with follow up.
- •Bilirubin > 1.5
- •Prior chemotherapy is not allowed
研究组 & 干预措施
Hormone Suppressors, Paclitaxel & Radiation therapy
Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months:
- Lupron / Flutamide
- Zoladex/ Flutamide
- Lupron/ Casodex
- Zoladex/ Casodex
Paclitaxel: 30 mg/m2 twice a week administered as a one hour infusion either Monday & Wednesday or Tuesday & Thursday for eight consecutive weeks will be started within the first week of radiation therapy. Following the first 3 dose levels, the dose of Paclitaxel will be escalated to 35 mg/m2 (dose level IV), 40 mg/m2 (dose level V) & 45 mg/m2 (dose level VI).
Radiation Therapy: 5 days a week for 8 weeks to a total dose of 66.6 to 73.8 Gray depending on when patient enter the study.
干预措施: Hormone Suppressors (Drug)
Hormone Suppressors, Paclitaxel & Radiation therapy
Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months:
- Lupron / Flutamide
- Zoladex/ Flutamide
- Lupron/ Casodex
- Zoladex/ Casodex
Paclitaxel: 30 mg/m2 twice a week administered as a one hour infusion either Monday & Wednesday or Tuesday & Thursday for eight consecutive weeks will be started within the first week of radiation therapy. Following the first 3 dose levels, the dose of Paclitaxel will be escalated to 35 mg/m2 (dose level IV), 40 mg/m2 (dose level V) & 45 mg/m2 (dose level VI).
Radiation Therapy: 5 days a week for 8 weeks to a total dose of 66.6 to 73.8 Gray depending on when patient enter the study.
干预措施: Paclitaxel (Drug)
Hormone Suppressors, Paclitaxel & Radiation therapy
Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months:
- Lupron / Flutamide
- Zoladex/ Flutamide
- Lupron/ Casodex
- Zoladex/ Casodex
Paclitaxel: 30 mg/m2 twice a week administered as a one hour infusion either Monday & Wednesday or Tuesday & Thursday for eight consecutive weeks will be started within the first week of radiation therapy. Following the first 3 dose levels, the dose of Paclitaxel will be escalated to 35 mg/m2 (dose level IV), 40 mg/m2 (dose level V) & 45 mg/m2 (dose level VI).
Radiation Therapy: 5 days a week for 8 weeks to a total dose of 66.6 to 73.8 Gray depending on when patient enter the study.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Number of participants with qualitative and quantitative toxicities
时间窗: up to 8 months
Maximum tolerated dose (MTD) assessment
时间窗: 8 weeks
The MTD will be the lowest dose at which 2/6 or 2/3 patients experience dose limiting toxicity (DLT)
次要结局
未报告次要终点