跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/ACTRN12611000245998
ACTRN12611000245998已完成2 期

Phase II trial to evaluate the potential molecular profile of biliary tract cancer and also examine the clinical benefit and safety of panitumumab, cisplatin and gemcitabine in the treatment of biliary tract cancer

Australasian Gastrointestinal Trials Group (AGITG)0 个研究点目标入组 45 人开始时间: 2011年3月7日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
45
研究概览研究设计入排标准研究者记录与标识符相似试验

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
18 Years 至 o limit（—）
性别
All

入选标准

  • •1.Histologic or cytologic diagnosis of adenocarcinoma of the gallbladder or intra/extrahepatic bile ducts with locally advanced or metastatic disease (at study entry) that is not amenable to curative surgical resection or with recurrent disease after prior surgical resection or radiotherapy;
  • •2.K-RAS wild-type oncogene;
  • •3.Uni-dimensional measurable disease as assessed by CT scan (RECIST v1.1 criteria).
  • •4.Patients must have received no prior chemotherapy or biological therapy for advanced disease;
  • •5.Prior radiotherapy must be completed at least 4 weeks before study enrolment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrolment;
  • •6.WHO performance status 0, 1 or 2;
  • •7.Estimated life expectancy of at least 12 weeks;
  • •8.Patient compliance and geographic proximity that allows adequate follow-up;
  • •9.Adequate organ function including the following:
  • •a.Adequate bone marrow reserve: absolute neutrophil count (ANC) of greater than or equal to 1.5 x109/L, platelet count of greater than or equal to 100 x109/L, and haemoglobin of greater than or equal to 9 g/dL.
  • •b.Hepatic: AST and ALT less than 5 x upper limit of normal (ULN); bilirubin less than 2 x ULN; in patients with obstructive jaundice and bilirubin greater than or equal 2 x ULN, internal or external biliary drainage should be performed before enrollment. Patients should be enrolled only if bilirubin declines to greater than or equal 2 x ULN.
  • •c.Renal: creatinine less than 1. 5 x ULN and calculated creatinine clearance greater than or equal to 50 mL/min, calculated according to the Cockcroft formula.
  • •10.Signed informed consent from patient or legal representative.
  • •11.Patients available to complete study requirements (visits, tests, evaluations and follow-up procedures) in a timely manner.
  • •12.Male and female patients with reproductive potential must use a reliable contraceptive method if appropriate (eg, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the study. Females with childbearing potential must have a negative urine pregnancy test within 7 days prior to study enrolment.

排除标准

  • •1.Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or comply with the study protocol;
  • •2.Heart failure, angina pectoris or arrhythmia that are poorly controlled in spite of medication or acute myocardial infarction within 6 months preceding study enrollment;
  • •3.Active infection that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy, especially uncontrolled biliary tract infections;
  • •4.Poorly controlled diabetes mellitus;
  • •5.Interstitial lung disease
  • •6.Any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator;
  • •7.Pregnancy or breast feeding or unwilling / unable to practice adequate contraception
  • •8.Second primary malignancy (except in situ carcinoma of the cervix or adequately treated non-melanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
  • •9.Pregnancy or breast feeding or unwilling / unable to practice adequate contraception.
  • •10.Documented brain metastasis.

研究者

发起方
Australasian Gastrointestinal Trials Group (AGITG)

相似试验

已完成
2 期
ANZ 0301 / BCIRG 103 (1839 IL / 0219) : Presurgical Study Evaluating IRESSAInvasive Breast CancerCancer - Breast
ACTRN12607000013460AstraZeneca Pharmaceuticals59
进行中（未招募）
不适用
Phase II clinical trial exploring the activity of crizotinib in patients with advanced solid tumors induced by causal alterations of specific receptors (ALK and MET/HGF receptor tyrosine kinases) expressed by cancer sells.ocally advanced and/or metastatic malignant tumor (anaplastic large cell lymphoma, inflammatory myofibroblastic tumor, papillary renal cell carcinoma type 1, alveolar soft part sarcoma, clear cell sarcoma or alveolar rhabdomyosarcoma) deemed incurable by conventional surgery, radiotherapy, systemic therapy or any other meansMedDRA version: 15.1Level: LLTClassification code 10065867Term: Alveolar rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1Level: PTClassification code 10002227Term: Anaplastic large cell lymphoma T- and null-cell typesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1Level: PTClassification code 10001882Term: Alveolar soft part sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2011-001988-52-ITE.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER582
招募中
2 期
A phase II trial to reveal safety and efficacy of TM5509 in allogeneic stem cell transplantation with TBI regimeHematologic Malignancy
JPRN-UMIN000018191Tohoku University School of Medicine, Molecular Medicine and Therapy, Toshio Miyata15
进行中（未招募）
1 期
Clinical Trial of allogeneic mesenchymal cells from umbilical cord tissue in patients with COVID-19.
EUCTR2020-001450-22-ESFundación de Investigación del Hospital Infantil Universitario Niño Jesús106
进行中（未招募）
1 期
ABORL - A Phase II trial aiming to evaluate the clinical interest of ABEMACICLIB in patients with locally advanced/metastatic head and neck cancer harboring an homozygous deletion of CDKN2A, and/or an amplification of CCND1 and/or of CDK6 refractory to standards treatmentsPatients with locally advanced/metastatic head and neck cancer after failure of platinum and cetuximab or anti-EGFR-basedMedDRA version: 20.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2016-004537-25-FRCentre Léon Bérard25