ACTRN12612001252808招募中2 期
A Phase II Study to evaluate progression free survival following Everolimus treatment in Patients with FDG-PET positive intermediate grade (Ki-67 3-20%) Pancreatic Neuroendocrine Tumours (PNETs)
Peter MacCallum Cancer Centre0 个研究点目标入组 20 人开始时间: 2012年11月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 19 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Newly diagnosed locally advanced or metastatic histologically confirmed pancreatic NET of intermediate grade (Ki67 of 3-20%), not suitable for radical or aggressive resection or hepatic-directed approaches (including ablation, TACE or SIRT therapy)
- •2) Functional imaging criteria:
- •(i)Disease must be FDG-avid and
- •(ii)Disease may or may not express somatostatin-receptor (SSTR) on In-111 octreotide SPECT/CT or Ga-68 octreotate PET/CT
- •3)Measurable/evaluable disease per RECIST Version 1.1,1 determined by relevant imaging based on disease site (i.e. by multiphase MRI or triphasic CT scan for hepatic metastasis)
- •4) ECOG PS 0-2
- •5) Age > 18 years
- •6)Adequate organ function
- •i)Bone marrow: Platelets > 100x10^9/L, Neutrophils > 1.5x10^9/L
- •ii) Liver: Bilirubin less than or equal to 2.5 xUNL, INR less than or equal to 1.3, AST/ALT less than or equal to 2.5 xUNL (if no hepatic metastases) or AST/ALT less than or equal to 5.0 xUNL (if hepatic metastases).
- •iii) Serum lipase and amylase less than and equal to 2 x ULN
- •iv) Renal: Creatinine clearance (CrCl) greater than and equal to 40mL/min (assessed by modified Cockroft-Gault or nuclear renal scan)
排除标准
- •1) Poorly differentiated pancreatic NET with Ki67 > 20%
- •2) Well differentiated pancreatic NET with Ki67 less than and equal to 2%, unless FDG-avid (in which case confirmatory re-biopsy with estimation of Ki67 is required. If on re-biopsy the ki67 is greater than 20% the patient will be excluded)
- •3) Patients requiring ongoing SSA for symptomatic control or control of hormone secretory syndromes
- •4) Patients who have received prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus)
- •5) Patients who have received any cytotoxic chemotherapy, targeted therapy, or biotherapy for pNETs
- •6) Patients with a known hypersensitivity to everolimus or other rapamycin analogs (sirolimus, temsirolimus) or to their excipients.
- •7) Prior treatment with radiolabelled SSAs within the last 12 months.
- •8) Patients with hepatic artery embolization, cryoablation or radiofrequency ablation of hepatic metastasis within the last 3 months prior to registration.
- •9) Patients who have received radiotherapy of target lesions, unless documented progression at that site.
- •10) Patients who have received local radiotherapy of non-target lesions for local symptom control within the last 2 weeks must have recovered from any adverse effects of radiotherapy prior to therapy.
- •11) Patients who have undergone major surgery/surgical therapy for any cause within 1 month.
- •12) Patients who have not recovered from any previous treatment for any cause and who have not reached ECOG performance status 0-2 before entering the study.
- •13) Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent.
- •14) Patients who are not biochemically euthyroid. Patients with a history of hypothyroidism are eligible if they are on adequate and stable replacement thyroid hormone therapy and have been for at least 3 months.
- •15) Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
- •i) Uncontrolled diabetes as defined by HbA1c greater than and equal to 8% despite adequate therapy,
- •ii) Fasting serum cholesterol > 7.75 mmol/L or fasting triglycerides > 2.5 ULN despite appropriate lipid lowering medication.
- •iii) Severely impaired lung function defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air. DLCO should be adjusted to haemoglobin value and patient lung volumes.
- •iv) Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive HIV test result (ELISA and Western blot)
- •v) Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment.
- •vi) Liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis or chronic persistent hepatitis, except carriers of or chronic hepatitis B and C.
- •16) Patients who have a history of another primary malignancy within the last 3 years, with the exception of locally excised non-melanoma skin cancer and carcinoma in situ of uterine cervix
- •17) Symptomatic CNS metastases requiring corticosteroid therapy.
- •18) Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator or the Sponsor’s Medical Monitor.
- •19) Patients with a history of non-compliance to medical
研究者
相似试验
招募中
不适用
A Phase II Trial to Evaluate the Strategy of Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer (RESOLUTE)metastatic colorectal cancerCancer - Bowel - Back passage (rectum) or large bowel (colon)Cancer - Bowel - Small bowel (duodenum and ileum)ACTRN12621001198819Cancer Council Victoria50
招募中
2 期
Cisplatin and oral vinorelbine chemotherapy along with radiation for treatment of locally advanced lung cancerStage III Non Small Cell Lung CancerCancer - Lung - Non small cellACTRN12609000003279Royal Adelaide Hospital50
进行中（未招募）
不适用
A randomized phase II study of progression free survival comparing gemcitabine (1250 mg/m2 infusion) versus carboplatin (AUC5 infusion) plus alimta (500 mg/m2 infusion) as first-line chemotherapy in elderly patients with locally advanced (stage IIIb) or metastatic (stage IV) non small cell lung cancer (NSCLC) - NDEUCTR2008-002126-12-ITISTITUTO CLINICO HUMANITAS
撤回
2 期
A Phase II study of midostaurin in combination with standard chemotherapy in newly diagnosed patients with Core Binding Factor Acute Myeloid LeukaemiaACTRN12612000847819Australasian Leukaemia and Lymphoma Group50
进行中（未招募）
不适用
An exploratory, prospective phase II study to investigate progression-free survival, response and overall survival seen with pemetrexed/cisplatin and the role of thymidylate synthase expression.Advanced non-squamous non small cell lung cancerMedDRA version: 9.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBMedDRA version: 9.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVEUCTR2008-006709-18-GBEli Lilly and Company Limited68