NCT06648785Enrolling By Invitation2 期
Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients With GI Malignancies
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Tolerability
研究概览
简要总结
This study is a single arm, non-randomized feasibility study with tolerability and toxicity evaluation as primary endpoints which seeks to determine if a modified administration schedule of capecitabine with oxaliplatin will result in less toxicity than standard FOLFOX or CAPOX regimens.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with GI malignancy
- •Provider plans non-curative intent treatment with either CAPOX or FOLFOX (mFOLFOX6) at standard dosages for >3 months NOTE: Patient is not required to have radiologically measurable disease. NOTE: Planned administration of other anti-cancer medications (eg bevacizumab, epidermal growth factor receptor antibodies, immunotherapy, tyrosine kinase inhibitors) is allowed.
排除标准
- •Patients not meeting standard hematologic parameters for chemotherapy administration as follows:
- •Absolute neutrophil count (ANC) ≥ 1500
- •Platelet count ≥ 100,000 Patients not meeting standard liver function parameters for chemotherapy administration as follows:
- •AST ≤ 5x ULN
- •ALT ≤ 5X ULN
- •Total Bilirubin ≤ 1.5X ULN Patients not meeting standard renal function parameters for chemotherapy administration as follows:
- •Serum Creatinine ≤ 1.2 or creatinine clearance ≥ 30 ml/min NOTE: Planned administration of another cytotoxic chemotherapy (eg irinotecan) is an exclusion.
研究组 & 干预措施
Modified administration schedule of capecitabine with oxaliplatin
Experimental
- Oxaliplatin (85mg/m2), will be administered IV every 2 weeks
- Capecitabine (1000mg/m2) will be given twice daily, administered orally (PO) for 7 days, followed by 7 days with no capecitabine Cycles will repeat every 14 days.
干预措施: oxaliplatin (Drug)
Modified administration schedule of capecitabine with oxaliplatin
Experimental
- Oxaliplatin (85mg/m2), will be administered IV every 2 weeks
- Capecitabine (1000mg/m2) will be given twice daily, administered orally (PO) for 7 days, followed by 7 days with no capecitabine Cycles will repeat every 14 days.
干预措施: Fluoropyrimidine (Drug)
结局指标
主要结局
Tolerability
时间窗: 115 days
Number of toxicity-related treatment delays Number of dose reductions
Toxicity
时间窗: 115 days
Severity of acute oxaliplatin reactions, graded 1-4
Neuropathy
时间窗: 2-4 months after therapy
Neuropathy will be graded 1-4 after 2 \&4 months of severity
Cytopenias
时间窗: 115 days
Frequency of cytopenia grade 3 or higher.
次要结局
- Tumor response(115 days)
研究者
Randall F Holcombe
Director-Faculty
University of Vermont Medical Center
研究点 (2)
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