EUCTR2008-007497-37-FR进行中（未招募）1 期
ESSAI EN DEUX ETAPES DE L’EVALUATION DE LA LENALIDOMIDE (REVLIMID®) DANS LE CANCER DE L’OVAIRE EN RECHUTE TARDIVE (> 6 MOIS): - EN MONOTHERAPIE CHEZ DES PATIENTES ASYMPTOMATIQUES AVEC UNE ELEVATION DU TAUX DE CA125 (PHASE II) ; - PUIS EN ASSOCIATION AVEC DU CARBOPLATINE ET DE LA DOXORUBICINE LIPOSOMALE PEGYLEE (PHASE I). - REV
ARCAGY0 个研究点开始时间: 2009年3月12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
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
- 性别
- Female
入选标准
- •Stage A: Patients
- •- aged > 18 years.
- •- with a histological proven diagnosis of epithelial cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors.
- •- with asymptomatic disease in progression detected by increase of CA 125 levels according to GCIG criteria during systematic follow-up.
- •- with disease in progression > 6 months after a first or second line including a platinum derivative. Patients should have received previously a taxane derivative.
- •- No dose modification in the previous lines of chemiotherapy, nor G-CSF use.
- •- Adequate bone marrow, renal and hepatic function defined as:. WBC > 3.0 x 109/L or Neutrophils (ANC) > 1,5 x 109/L; Platelets > 100 x 109/L; Hemoglobin > 6 mmol/L (10,0 mg/dL); Bilirubin < 2 x upper normal limit of normal range; Estimated glomerular filtration rate > 50 ml/mn according to Cockroft-Gault formula.
- •- with ECOG performance status = 0 or 1.
- •- with a life expectancy of at least 16 weeks
- •- who have given their signed and written informed consent to participate in the trial after fully understanding the implication and constraints of the protocol.
- •Stage B: Patients
- •- aged > 18 years.
- •- with a histological proven diagnosis of epithelial cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors.
- •- with disease in progression > 6 months after a first or second line including a platinum derivative. patients should have received previously a taxane derivative.
- •- Patients included in stage A with disease in progression under lenalidomide could be eligible in phase B if they did not experience unacceptable toxicity under lenalidomide in stage A.
- •- No dose modification in the previous lines of chemiotherapy, nor G-CSF use.
- •- Adequate bone marrow, renal and hepatic function defined as:. WBC > 3.0 x 109/L or Neutrophils (ANC) > 1,5 x 109/L; Platelets > 100 x 109/L; Hemoglobin > 6 mmol/L (10,0 mg/dL); Bilirubin < 2 x upper normal limit of normal range; Estimated glomerular filtration rate > 50 ml/mn according to Cockroft-Gault formula.
- •- with LVEF under noral range
- •- with ECOG performance status = 0 or 1.
- •- with a life expectancy of at least 16 weeks.
- •- who have given their signed and written informed consent to participate in the trial after fully understanding the implication and constraints of the protocol.
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Ovarian tumors of low malignant potential (borderline tumors).
- •- Non-epithelial ovarian or mixed epithelial/non epithelial tumors (e.g. mixed Mullerian tumors).
- •- Patients with a prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
- •- Patients who have received previous radiotherapy.
- •- Presence of symptomatic brain metastases.
- •- Patients with a history of seizure disorder or central nervous system disorders; pre-existing motor or sensory neurologic pathology or symptoms > NCI-CTC grade 1.
- •- History of congestive heart failure (NYHA Classification > 2, even if medically controlled. History of clinical and electrocardiographically documented myocardial infarction within the last 6 months. History of atrial or ventricular arrhythmias (= LOWN II).
- •- Thrombosis or anti-thrombosis treatment within 6 months.
- •- History of visceral bleeding, gastro-intestinal ulcer in 6 months.
- •- Obstructive or sub-occlusive disease.
- •- Patients with severe active infection.
- •- Concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
- •- Fertile women not using adequate contraceptive methods, or who are pregnant or breast feeding.
- •- Histories of allergy or sentimentality known about the similar chemical compounds in the carboplatine, either in the doxorubicine liposomale pégylée, or in one of the constituents of the lenalidomide.
- •- Patient having developed a knotty erythema characterized by a rash with desquamation during grip(taking) of thalidomide or a medicine similaire.
- •- Previous administration of lenalidomide.
- •- Seropositivity known about the virus of the human immunodeficiency (HIV), or pathology bound to the syndrome of acquired immunodeficiency (AIDS) or hepatitis activates type A, B or C.
- •- Administration of other simultaneous chemotherapeutic drugs, or hormonal therapy, or simultaneous radiotherapy during the study treatment period (hormone replacement therapy is allowed as are steroid antiemetics).
- •- Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.
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