EUCTR2005-006070-10-GR进行中（未招募）不适用
Randomized phase III study ofLipoplatin + paclitaxelversuscisplatin + paclitaxelas front line treatmentof advanced epithelial ovarian cancer (EOC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Regulon Inc.
- 入组人数
- 200
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
- •Patients must meet the following criteria within 30 days prior to study entry (Day 0) unless otherwise noted
- •Adult females: over 18 years of age
- •Patients must have a histological or cytological confirmation of advanced ovarian cancer (Stage III/IV) either locally advanced or metastatic
- •Patients must have a performance status 0-2 (WHO)
- •Patients with asymptomatic brain metastases are eligible
- •Patients with brain metastases are eligible if they had a standard brain radiation therapy and they showed respone to radiation
- •Patients with prior radiotherapy are eligible
- •Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of over 2,000/mm3 and platelet count of 100,000/mm3)
- •Patients must have adequate liver function (bilirubin is less or equal to 1.5 mg/dl, SGOT, or SGPT no greater than 4 times normal)
- •Patients must have adequate renal function (creatinine less than 1.5 mg/dl).
- •All patients must have a life expectancy of at least 3 months
- •Patients must understand and sign an informed consent document that explains the neoplastic nature of his/her disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, and potential risks and toxicities.
- •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
- •Less than 3 weeks since prior major surgery
- •Malnutrition (>25% weight loss).
- •Other neoplasm
- •Prior chemotherapy
- •Pregnant or nursing women. Women with reproductive potential must have a negative pregnancy test and must use adequate contraception
- •Patients with active ischemic heart disease, a recent history of myocardial infarction (within the last 6 months), history of congestive heart failure, ventricular arrythmias or other arrythmias requiring therapy
- •Patients known to be HIV-positive
- •Patients known to have active Hepatitis B or C (i.e. detectable HBS Antigen or HC Ab)
- •Patients with underlying immune deficiency or history of autoimmune diseases e.g. (autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, active Graves' disease, or other diseases which qualify as autoimmune in origin)
- •Patients with dementia or with significantly altered mental status that would preclude to sign an informed consent
- •Patients will be ineligible if, in the opinion of the principal or associate investigators, it is not in the best medical interest of the patient to enter this study.
研究者
相似试验
进行中（未招募）
1 期
Prospective Randomized Phase-III-Trial of Paclitaxel plus Topotecan versus Topotecan plus Cisplatin in Recurrent or Persistent Cervical Carcinoma - AGO-Zervix-1Chemotherapeutical treatment of patients with recurrent or persistent or metastatic cervical carcinoma stage IVbEUCTR2006-000349-20-BEInstitut fuer Frauengesundheit GmbH173
进行中（未招募）
1 期
Patients in Recurrent or Persistent Cervical CarcinomaEUCTR2006-000349-20-DEInstitut fuer Frauengesundheit GmbH326
进行中（未招募）
不适用
Prospective Randomized Phase-III-Trial of Paclitaxel plus Topotecan versus Topotecan plus Cisplatin in Recurrent or Persistent Cervical Carcinoma - AGO-Zervix-1Chemotherapeutical treatment of patients with recurrent or persistent or metastatic cervical carcinoma stage IVbEUCTR2006-000349-20-ATInstitut fuer Frauengesundheit GmbH312
进行中（未招募）
1 期
Study comparing the efficacy of paclitaxel-bevacizumab with docetaxel in 2nd or 3rd treatment of lung canceron squamous non small cell lung cancer of advanced stageMedDRA version: 14.1Level: LLTClassification code 10025062Term: Lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-004524-38-FRIFCT
已完成
2 期
A clinical trial to study the effects of carboplatin / Paclitaxel and a new drug, CS- 7017, in patients with Non-Small Cell Lung CancerCTRI/2010/091/000491Daiichi Sankyo Pharma Development399 Thornall StreetEdison, NJUSA115