EUCTR2017-004099-71-IT进行中（未招募）1 期
Randomized Phase II study on Decitabine plus Carboplatin versus physician’s choice chemotherapy in recurrent, platinum-resistant ovarian cancer - MITO 29
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 119
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
- •1. Cytologic / histologic diagnosis of stage IC-IV epithelial , fallopian tube and primary peritoneal cancer (carcinosarcomas are included)
- •2. Patient who received 1-2 prior lines of treatments
- •3. Patient relapsed within 6 months after platinum containing regimen
- •4. Disease measurable or evaluable by RECIST version 1.1 or Ca 125 GCIG criteria
- •5. No residual peripheral neurotoxicity > Grade 1 from previous chemotherapy treatment
- •6. PS 0-1
- •7. Age >18 years.
- •8. Life expectancy of at least 3 months
- •9. Written informed consent prior to performance of study specific procedures or assessments
- •10. Ability and willingness to comply with treatment and follow up assessments and procedures
- •11. Adequate organ functions:
- •- Hematopoietic: Leukocytes > 2,500/mm3; Absolute neutrophil count >1,500/mm3; Platelets count >100,000/mm3; Hemoglobin >9 g/dL
- •- Hepatic: AST and ALT <3 times upper limit of normal (ULN)*; Alkaline phosphatase <3 times ULN*; Bilirubin <1.5 times ULN
- •*: <5 times ULN if liver metastases are present
- •- Renal: Creatinine clearance >45 mL/min
- •12. No other invasive malignancy within the past 3 years except non-melanoma skin cancer and in situ cervical cancer
- •13. Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule.
- •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 99
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Pregnant (potentially fertile patients must use contraceptive measures to avoid pregnancy during and for at least 3 months after study participation and must have a negative serum
- •pregnancy test at baseline).
- •2. Patients should not be breast-feeding during treatment and for 2 months following the end of treatment.
- •3. Serious heart disease, including heart failure, atrio-ventricular block of any degree, serious arrhythmia or history of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
- •4. Active infection requiring antibiotics.
- •5. History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
- •6. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
- •7. Patients who had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with < Grade 2 neuropathy or = Grade 2 alopecia are an exception to this criterion and may qualify for the study.
- •8. Patients with evidence of interstitial lung disease.
- •9. Major surgical procedure, open biopsy, or significant traumatic injury within 3 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded.
- •10. Known hypersensitivity to the study drugs or to drugs with similar chemical structures.
- •11. Concurrent treatment with other experimental drugs.
- •12. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
研究者
相似试验
招募中
1 期
Decitabine/carboplatin combination treatment protocol for metastatic melanomaMetastatic melanomaCancer - Malignant melanomaACTRN12616000440426niversity of Newcastle10
进行中（未招募）
1 期
A study of Decitabine with or without Hydroxyurea in people with with advanced proliferative Chronic Myelomonocytic Leukemia (CMML)Proliferative Chronic Myelomonocytic Leukemia (CMML)MedDRA version: 17.0Level: LLTClassification code 10054350Term: Chronic myelomonocytic leukemiaSystem Organ Class: 100000004864EUCTR2014-000200-10-ITFondazione Italiana Sindromi Mielodisplastiche (FISM Onlus)168
进行中（未招募）
1 期
A study of Decitabine with or without Hydroxyurea in people with with advanced proliferative Chronic Myelomonocytic Leukemia (CMML)Proliferative Chronic Myelomonocytic Leukemia (CMML)MedDRA version: 19.1Level: LLTClassification code 10054350Term: Chronic myelomonocytic leukemiaSystem Organ Class: 100000004864EUCTR2014-000200-10-DEGroupe Francophone des Myélodysplasies (GFM)168
已完成
1 期
Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or NeuroblastomaRecurrent NeuroblastomaUnspecified Childhood Solid Tumor, Protocol SpecificNCT00075634National Cancer Institute (NCI)21
进行中（未招募）
不适用
A Phase II study of Decitabine in patients with Chronic Myelomonocytic Leukemia - GFM-DEC-LMMC-2007-02Chronic Myelomonocytic LeukemiaEUCTR2008-000470-21-FRGroupe Francophone des Myélodysplasies