NCT02469116终止2 期
Phase II Trial of Carboplatin Plus Docetaxel With Day 2 Pegylated G-CSF (Neulasta®) in the Front-line Treatment of Patients With Advanced Stage Ovarian Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3
研究概览
简要总结
In this study the investigators will be using an AUC of 6 based on creatinine clearance using the Carboplatin dosing formula used for Gynecologic Oncology Group protocols.
Given that myelosuppression was significant using the docetaxel dose of 75 mg/m*2 in the SCOTROC trial, the prophylactic use of pegylated G-CSF in this Phase II trial is warranted. The expectation would be that patients will be able to receive their cycles in a more timely fashion, with less delays, thereby allowing for improved outcomes and decreased hospitalizations due to myelosuppression.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed newly diagnosed Stage III/IV epithelial ovarian or primary peritoneal carcinoma at time of initial diagnosis
- •Treatment must start within 8 weeks of surgery
- •Subjects may be measurable per RECIST criteria or evaluable for disease response by CA
- •Evaluable CA 125 levels are defined as an elevated CA125 pre operatively which either remains elevated post-operatively or normalizes after surgery
- •No prior chemotherapy or radiation therapy
- •Performance Status must be ≤ 2 (ECOG)
- •Peripheral neuropathy: must be ≤ grade 1
- •Hematologic (minimal values)
- •Absolute neutrophil count ≥ 1,500/mm3
- •Hemoglobin ≥ 8.0 g/dl
- •Platelet count ≥ 100,000/mm3
- •*Total Bilirubin ≤ ULN
- •AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
- •If alkaline phosphatase is ≤ ULN and AST or ALT is >5x ULN then the patient is not eligible
- •If alkaline phosphatase is >1x but ≤2.5 x the ULN and the AST or ALT is >1.5x the ULN then the patient is not eligible
- •If alkaline phosphatase is >2.5x but ≤5x the ULN and the AST or ALT is >1x the ULN then the patient is not eligible
- •If alkaline phosphatase is >5x the ULN then the patient is not eligible
- •Renal: Creatinine (serum) less than or equal to 1.5 ULN, CTC grade
- •Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- •PT/PTT ≤ 1.5 x's ULN
排除标准
- •Patients with a history of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate
- •Women who are pregnant or breast-feeding.
- •Patients who have signs of infection or who have not recovered from the effects of recent surgery
- •Patients with a performance status of 3 or 4
- •Patients with a second malignancy within past 5 years other than non-melanoma skin carcinoma.
- •Patients who have received prior myelosuppressive chemotherapy or XRT.
研究组 & 干预措施
Arm 1: (docetaxel, carboplatin, pegylated G-CSF)
Experimental
- Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
- Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles
干预措施: Docetaxel (Drug)
Arm 1: (docetaxel, carboplatin, pegylated G-CSF)
Experimental
- Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
- Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles
干预措施: Carboplatin (Drug)
Arm 1: (docetaxel, carboplatin, pegylated G-CSF)
Experimental
- Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
- Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles
干预措施: Pegylated G-CSF (Drug)
结局指标
主要结局
Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3
时间窗: Through 30 days after completion of treatment (approximately 22 weeks)
次要结局
- Efficacy of Regimen as Measured by CA-125 Response(Completion of treatment (approximately 18 weeks))
- Time to Progression (TTP)(Completion of follow-up)
- Overall Survival (OS)(Completion of follow-up)
- Quality of Life (QoL) as Measured by FACT-O Assessment Tool(Completion of follow-up)
- Progression-free Survival (PFS)(Completion of follow-up)
研究者
研究点 (1)
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