A Phase II Pilot Study Investigating the Efficacy and Activity of Single Agent GM-CSF (Leukine) Maintenance Approach in Androgen-independent Prostate Cancer (AIPC) Patients Responding to Taxotere Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Time to Disease Progression (TTP)
研究概览
简要总结
This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance program in patients with androgen-independent prostate cancer (AIPC) who have achieved a maximal response on a taxotere or other chemotherapy schedule.
详细描述
Patients will be treated on this single arm, open label trial until primary end point is met, patient's withdrawal, or investigator's discretion. After achieving a maximal response on taxotere or other chemo schedule they were eligible to enroll in this trial and begin treatment with maintenance GMCSF for 2 weeks followed by 2 weeks of rest. Once progression was documented the patients were taken off study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men >18 years of age. No upper age limit
- •Written informed consent approved by institutional review board should be explained to and signed by patient
- •Documentation of histologically confirmed adenocarcinoma of the prostate. Gleason score of any sum is allowed on this study.
- •Metastatic disease as evidenced by visceral involvement, bone disease, or PSA elevation.
- •Patients should meet the criteria of androgen independent prostate cancer (AIPC). Patients would fulfill these criteria if they continue to progress despite complete androgen blockade (surgical or medical castration with anti-androgen) and despite an anti-androgen withdrawal trial. Failing anti-androgen withdrawal is defined as no decline by 25% or more 3-weeks after stopping anti-androgens.
- •Progression on hormonal therapy is defined as ANY of the following:
- •PSA: 2 consecutive rising PSA values, at least 14-days apart, each being > 5 ng/ml
- •For patients with visceral measurable disease, progression is defined as an increase by 50% or more in the size of measurable areas, or any development of new lesions.
- •For patients with bone-only disease, progression is defined as the appearance of 2 or more new areas of abnormal uptake on a bone scan, when compared to prior imaging studies. Changes in the uptake of already existing lesions will NOT be used to define progressive disease.
- •For patients with bone AND visceral disease, fulfilling any of the criteria in 5.2 or 5.3 is sufficient to define progression.
- •Castration levels of testosterone (< 50 ng/dl) achieved via medical or surgical castration. Patients should continue on LHRH agonists throughout if this is the method used to achieve castration.
- •Life expectancy of at least 6 months
- •Adequate hematologic, renal, and liver function as evidenced by the following:
- •WBC > 2000,
- •ANC > 1000,
- •Platelet count > 100,000,
- •HgB > 9.0 g/dl, Creatinine < 2,
- •Total bilirubin < 2x upper limit of normal,
- •AST and ALT < 3 x upper limit of normal
- •ECOG performance status of 0 or
- •The use of intravenous polyphosphates for bone metastases is allowed.
- •upon completion of the taxotere portion of study, patient can be enrolled & receive GM-CSF if ANY of the following criteria is met:
- •Patients received total of 8 cycles of taxotere & have no signs of disease progression
- •Patients achieved their maximal response despite receiving < than 8 cycles of taxotere. Maximum response is defined as a drop in measures of PSA by 10% or less on 2 consecutive measurements.
- •Patients who have completed their chemotherapy < than 12 weeks prior to opening this trial & still have stable disease without progression (by PSA and radiographically) will be eligible to receive maintenance GM-CSF
排除标准
- •presence of brain metastases
- •Known HIV+ status
- •ECOG performance status of 2 or higher
- •Use of investigational agents within 4 weeks of starting
- •Patients with prior exposure to more than one chemotherapy program Patients who have received one chemotherapy schedule can be enrolled on study and receive GM-CSF (the maintenance arm) if their last chemotherapy was taxotere, given within the past 12 weeks, and they have demonstrated NO evidence of progression radiographically and biochemically. Prior exposure to steroids is NOT an exclusion criteria.
- •Patients with other active malignancies (excluding non-melanoma skin cancers)are excluded. Prior malignancies are not exclusion criteria as long as last treatment for such malignancies was over 5 years prior to enrollment.
- •Treatment with investigational products are NOT an exclusion criteria, if therapy was last received over 4 weeks prior to enrollment.
- •Any medical intervention or other condition which, in the opinion of the principle investigator, could compromise adherence with study requirements.
研究组 & 干预措施
GM-CSF
Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GM-CSF as outlined in the protocol
干预措施: GM CSF (Drug)
结局指标
主要结局
Time to Disease Progression (TTP)
时间窗: up to 21 months
The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported
次要结局
- Median Overall Survival (OS)(up to 44 months)
- Response Rate (Radiographic)(up to 21 months)
- Response Rate (PSA)(up to 21 months)
- Median Number of GM-CSF Cycles(up to 12 months)
研究者
Dr. Sigrun Hallmeyer
Principal Investigator
Oncology Specialists, S.C.