An Open-Label, Randomised Study of Multi-Cycle, Dose Intensive Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 61
- 主要终点
- PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time.
研究概览
简要总结
The purpose of this study is to provide dose-finding information regarding the efficacy and kinetics of peripheral blood progenitor cell (PBPC) mobilisation by pegfilgrastim and to determine if carboplatin/paclitaxel can be delivered at a reduced cycle interval when supported by pegfilgrastim-mobilised PBPCs in whole blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diagnosis of malignancy (solid tumour) suitable for treatment with intensified carboplatin and paclitaxel - Previously untreated with chemotherapy or radiotherapy - ECOG performance status 0 to 2 inclusive - Life expectancy greater than or equal to 12 weeks - ANC greater than or equal to 2.0 x 10^9/L, platelets greater than 100 x 10^9/L - Glomerular filtration rate greater than 60 mL/min
排除标准
- •Active infection requiring treatment with systemic (IV or oral) anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of randomisation - Known to be HIV positive - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) - Prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, and/or carcinoma of the cervix in-situ - History of impaired cardiac status [e.g., severe heart disease (NYHA greater than 2), cardiomyopathy, or congestive heart failure] - Bone marrow involvement of disease - Major surgery within 2 weeks before randomisation - Known sensitivity to E. coli derived drug products (e.g., filgrastim) - Previous exposure to pegfilgrastim
研究组 & 干预措施
Pegfilgrastim 18 mg
Pegfilgrastim 18 mg given once for mobilization
干预措施: carboplatin (Drug)
Pegfilgrastim 18 mg
Pegfilgrastim 18 mg given once for mobilization
干预措施: paclitaxel (Drug)
Pegfilgrastim 18 mg
Pegfilgrastim 18 mg given once for mobilization
干预措施: pegfilgrastim (Drug)
Filgrastim
Filgrastim given daily for mobilization
干预措施: carboplatin (Drug)
Filgrastim
Filgrastim given daily for mobilization
干预措施: paclitaxel (Drug)
Pegfilgrastim 12 mg
Pegfilgrastim 12 mg given once for mobilization
干预措施: carboplatin (Drug)
Pegfilgrastim 12 mg
Pegfilgrastim 12 mg given once for mobilization
干预措施: paclitaxel (Drug)
Pegfilgrastim 12 mg
Pegfilgrastim 12 mg given once for mobilization
干预措施: pegfilgrastim (Drug)
Pegfilgrastim 6 mg
Pegfilgrastim 6 mg given once for mobilization
干预措施: carboplatin (Drug)
Pegfilgrastim 6 mg
Pegfilgrastim 6 mg given once for mobilization
干预措施: paclitaxel (Drug)
Pegfilgrastim 6 mg
Pegfilgrastim 6 mg given once for mobilization
干预措施: pegfilgrastim (Drug)
结局指标
主要结局
PBPC mobilization profiles and success rate of achieving planned chemotherapy administration on time.
时间窗: Cycle 0, and through 4 cycles
次要结局
- PBPC kinetics and response to chemotherapy treatment(Cycles 1-4)