NCT00864318已完成2 期
Dose Intensification Phase II Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis. TICE Protocol : Paclitaxel and Ifosfamide Followed by Carboplatine and Etoposide Intensification With Individual Carboplatine Dose Adjustment.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 18
- 主要终点
- Complete response rate(by chemotherapy or chemotherapy + surgery), pathological complete response rate.
研究概览
简要总结
Not randomized, multicentric, national phase II trial estimating the efficacy of an intensification protocol in patients with refractory germ cell tumors with relapse and bad prognosis.
Treatment consists in two Paclitaxel and Ifosfamide intensification cycles followed by three Carboplatine and Etoposide high dose cycles. The point is the individual Carboplatine adjustment to take into account inter-individual patients variability.
This adaptation allow to control each patient plasmatic exposition to avoid both inacceptable toxicities (such as ear toxicity) and a low exposition losing then the benefit of this high dose protocol.
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
- •Germ cell tumors whatever histology (TGNS or séminoma : TGS ) whose origin is gonadic, extra-gonadic, retro-peritoneal or primitive mediastinal
- •Age >= 18 years old
- •Histologically confirmed germ cell tumor (TGS) or biomarkers rate allowing to diagnose germ cell tumor without histology (TGNS)
- •Relapse or progression with bad prognosis in 1st treatment line : One of these criteria valid point 4 :
- •progression after incomplete clinical response (Stable disease) to a Cisplatin basis chemotherapy; biomarker progression 4 weeks following the last chemotherapy cycle administration; progression during the first treatment line without obtention of at least stable disease; primitive mediastinal origin in first relapse.
- •TGNS or TGS in relapse after 2 treatment lines
- •Disease progression ( previous points 4 or 5) documented by :
- •tumors biomarkers increase (AFP and/or HCG) if no, a biopsy is needed to confirm presence of tumors active cells
- •ECOG Performance status 0-2
- •Biological Function :
- •Neutrophils >= 1500/mm3, Platelets >= 150.000/mm3 ; normal creatinine (or clearance >= 50 ml/mn) ; SGOT, SGPT <= 2,5N (or 5N if hepatic metastases), Bilirubin < 1,5N
- •Cardiac Functions (FEV >= 50%), Respiratory Functions , neurological Functions compatibles with high dose chemotherapy administration
- •Absence of previous intensification
- •Patient Information and Informed consent signature
- •HIV and B and C hepatitis negative serologies
- •Negative pregnancy test for women with reproductive potential and adequate contraception before study entry
- •Patient affiliated to social security system
排除标准
- •Patients whose diagnosis of relapse was not confirmed by an anatomopathological examination or by an increase of tumors markers
- •Primitive encephalic germ cell tumors
- •Germ cell tumors in relapse with favorable factors of treatment response to conventional chemotherapy (RC sustainable after Cisplatin): prior cRC or incomplete clinical response but with normalization of markers and testicular origin
- •Growing Teratoma lesions
- •Patients with HIV infection, hepatitis B and C
- •Patients with symptomatic brain metastases despite appropriate corticosteroid treatment
- •Associated pathology may prevent the patient to receive treatment, creatinine clearance ≤ 50 mL / min (calculated by Cockcroft-Gault)
- •History of cancer (except basal cell epithelioma skin cancer) in the 3 years preceding the entry into the trial
- •Patient already included in another clinical trial involving an experimental molecule
- •Pregnant or breast feeding women
- •Persons without liberty or under guardianship,
- •Geographical, social or psychological conditions that do not permit compliance with protocol
结局指标
主要结局
Complete response rate(by chemotherapy or chemotherapy + surgery), pathological complete response rate.
时间窗: 6 months
次要结局
- Progression free survival(8 years)
- Time to progression(8 years)
- Genetic polymorphisms involved in response and safety treatments(4 years)
- Toxicity(6 months)
- To find a predictive value for Cystatin C as a biomarker of renal function to avoid next to follow plasmatic concentrations to adapt Carboplatine dose in TICE protocol.(4 years)
- Etoposide pharmacokinetics (in particular inter-individual variability of Etoposide plasmatic concentrations AUC in such patients(4 years)
研究者
研究点 (18)
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