ACTRN12616000958482进行中（未招募）2 期
A phase II study to establish if carboplatin and nab-paclitaxel combination is an effective and tolerable chemotherapy treatment for grade 3 advanced gastrointestinal Neuroendocrine Carcinomas.
Australasian Gastro-Intestinal Trials Group (AGITG)0 个研究点目标入组 60 人开始时间: 2016年7月21日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adults, aged 18 years and older, with advanced and/or metastatic, unresectable neuroendocrine carcinoma
- •-Histologically proven (WHO/ ENET) Grade 3 NEC with Ki-67 greater than 20%. (The features of small versus large cell NEC carcinoma will need to be documented and participants with Mixed AdenoneuroEndocrine Carcinomas (MANEC) are eligible if they have G3 elements)
- •-Tumour sufficiently FDG-avid on the initial staging PET Scan (e.g. SUVmax greater than or equal to 3.5). If avidity is borderline or unclear then contact the NHMRC CTC and Study Chair.
- •-Measurable disease as assessed by CT scan of the chest, abdomen and pelvis within 21 days prior to randomisation (according to RECIST 1.1)
- •-ECOG performance status 0-2
- •-Adequate bone marrow function (platelets greater than 100 x 109/L; ANC greater than 2 x 109/L; haemoglobin greater than 100 x g/L)
- •-Adequate liver function (total bilirubin less than or equal to 1.5 x ULN, ALT/AST less than or equal to 3 × ULN). For participants with liver metastases use the following ULN: total bilirubin less than or equal to 3 x ULN, ALT/AST less than or equal to 5 × ULN. NB; Patients with inadequate liver function and liver metastases who satisfy all other eligibility criteria may start on a reduced dose level (-1 dose level; see table 5.2.1), upon approval by the Study Chair or delegate. Doses can be increased to the standard starting doses if AST/ALT normalise.
- •-Adequate renal function (creatinine less than or equal to 1.5 ULN)
- •-Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- •-Signed, written informed consent (main study)
排除标准
- •-NECs confirmed not to be from gastrointestinal primaries
- •-Grade 1 and Grade 2 NETs (Ki-67 less than or equal to 20%)
- •-Suspected pulmonary origin of the NET
- •-Known hypersensitivity to nab-paclitaxel
- •-External beam radiotherapy to solitary target lesions. Patients who have received local radiotherapy of non-target lesions for local symptom control within the last 4 weeks must have recovered from any adverse effects of radiotherapy prior to randomization.
- •-Prior intrahepatic 90Y-microspheres such as SIR-Spheres
- •-Major surgery/surgical therapy for any cause within 1 month
- •-Surgical therapy of loco-regional metastases within the last 3 months prior to randomization
- •-Severe cardiovascular, hepatic, neurologic or renal comorbid conditions
- •-Previous cytotoxic chemotherapy, or targeted therapy, or biotherapy within the last 4 weeks (excluding SSAs)
- •-Significant infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated
- •-Sensory/motor neuropathy greater than or equal to G2, as defined by NCI CTCAE 4.0
- •-Life expectancy of less than 3 months
- •-History of another malignancy within 2 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years after definitive primary treatment, or in the case of stage 1 tumour/s are undergoing curative resection and there is no indication for chemo- or radiotherapy.
- •-Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
- •-Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception
研究者
相似试验
未知
2 期
Phase II study in combination with Carboplatin and TS-1 for Cancer of unknown primaryCancer of unknown primaryJPRN-UMIN000001236ational Cancer Center Hospital, Tokyo35
招募中
1 期
A phase I/II study of carboplatin in combination with nab-paclitaxel and thoracic radiation in elderly patients with previously untreated non-small cell lung cancerocally Advanced Non-Small Cell Lung CancerJPRN-UMIN000016730Foundation for Biomedical Research and Innovation43
进行中（未招募）
不适用
A randomised Phase II study of carboplatin with or without the addition of the ETAR inhibitor ZD4054 as treatment for patients with metastatic breast cancer. - PLANETMetastatic Breast CancerEUCTR2010-018837-23-GBCardiff University
已完成
不适用
Carboplatin with or without ZD4054 in patients with metastatic breast cancerMetastatic breast cancerCancerISRCTN73466214Cardiff University (UK)138
已完成
2 期
A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancerJPRN-C000000097West Japan Oncology Group90