EUCTR2006-001065-41-GB进行中（未招募）1 期
Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in refractory and relapsed pediatric solid tumors. - ITCC-004-GEMOX
niversity Hospitals of Leicester NHS Trust, Research and Development Directorate0 个研究点目标入组 156 人开始时间: 2007年2月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Histologically or cytologically confirmed malignant solid tumor (at diagnosis)
- •Relapsed or refractory tumors in which correct standard treatment approaches have failed
- •Measurable primary and/or metastatic disease: at least one bi-dimensionally measurable lesion.
- •For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993).
- •For patients with osteosarcoma, measurable lesions are lung metastases and osseous lesions with soft tissue tumor, in exclusion of completely calcified or necrosed lesion at study entry. A patient with an unique osseous lesion without soft tissue mass can be included in the study if the lesion is operable and thus accessible for histological response assessment.
- •No more than one salvage therapy for relapse
- •Age at inclusion: 6 months to = 20 years
- •Lansky play score ³ 70% or ECOG performance status = 1
- •Life expectancy ³ 3 months•Adequate organ function:Adequate hematological function: neutrophil count ³ 1.0 x 109/L, platelet count ³ 100 x 109/L; in case of bone marrow disease: ³ 75 x 109/L; hemoglobin ³ 8 g/dLAdequate renal function: creatinine <1.5 x ULN for age; If serum creatinine is > 1.5 ULN of age, then creatinine clearance (or radioisotope GFR) must be > 70 ml/min/1.73 m2Adequate hepatic function: bilirubin <1.5 x ULN; ASAT and ALAT <2.5 x ULN (ASAT, ALAT =5xULN in case of liver metastases).
- •Wash out of 3 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 4 weeks in case of prior radiotherapy. Patients must have recovered from the acute toxic effects of all prior therapy before enrollment into the study.
- •Able to comply with scheduled follow-up and with management of toxicity
- •All patients with reproductive potential must practice an effective method of birth control while on study. Female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment.
- •Written informed consent from patient, parents or legal guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Concurrent administration of any other antitumor therapy.
- •Have previously completed or withdrawn from this study or any other study investigating gemcitabine or oxaliplatin.
- •Have a serious concomitant systemic disorder (for example, active infection including HIV, or cardiac disease) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study
- •Pre-existing sensory or motor neuropathy >Grade 2 (excluding neuropathy due to disease and/or surgery)
- •History of allergic reaction to platinum compounds
- •Are pregnant or breast feeding
- •Presence of symptomatic brain metastases in patients with solid non-CNS tumors
研究者
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