EUCTR2013-000314-38-AT进行中（未招募）1 期
A randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs)
European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 220 人开始时间: 2016年3月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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
- All
入选标准
- •Inclusion Criteria for patients at registration:
- •? Histologically proven diagnosis of recurrent and/or metastatic salivary duct cancer; adenocarcinoma NOS; and AR expression level of =6 in nuclei of neoplastic cells based on central review (please refer to AR testing guidelines for more details) Sufficient tissue must be available either from a historical sample or a new biopsy must be done as a part of this study and sent for central review for patients to be enrolled in both cohorts;
- •? Presence of at least one uni-dimensional measurable lesion by CTscan or MRI according to RECIST criteria version 1.1 (target lesion). A lesion previously treated with radiotherapy can be chosen as a target lesion only if progression in the respective lesion has been demonstrated during or following radiotherapy;
- •? No actively bleeding tumor if the patient is intended to be treated with carboplatin
- •? Patients 18 years old or older;
- •? Performance Status ECOG 0-1;
- •? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
- •? Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Treatment naïve and pretreated patients will be enrolled in two distinct Cohorts during enrollment, Cohort A and Cohort B, respectively. The following selection criteria are valid for both Cohorts A and B:
- •? Central pathology confirmation of AR expression
- •? Adequate bone marrow function (within 2 weeks prior to treatment start):
- •- WBC = 3.5/109L
- •- absolute neutrophil count = 1,5x109/L
- •- hemoglobin > 10 g/dL or > 6.20 mmol/L
- •- platelet count = 100x109/L
- •? Adequate liver function (within 2 weeks prior to treatment start):
- •- AST < 2.5 times upper limit of normal
- •- ALT < 2.5 times upper limit of normal
- •- bilirubin < 1.5 times upper limit of normal
- •? Adequate renal function (within 2 weeks prior to treatment start):
- •- serum creatinine level (= 1.3 mg/dL)
- •- calculated creatinine clearance = 60 mL/min based on the standard Cockcroft and Gault formula
- •? Adequate cardiac function as demonstrated by a clinically normal 12 lead ECG (triplicate method) and normal left ventricular ejection fraction (LVEF) = 50% (within 2 weeks prior to treatment start) either by echocardiography or multi-gated radionuclide angiography (MUGA) as per national guidelines.
- •? Absence of any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia and vitiligo
- •? Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 1 week prior to the first dose of study treatment and prior to the start of every cycle.
- •? Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator and the Clinical Trials Facilitation Group (CTFG) guidelines, during the study treatment period based on national guidelines and clinical judgment of participating investigator and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly; women should not breastfeed a baby while on this study
- •- The highly effective methods of contraception include total sexual abstinence, combine (estrogen and progestogen
排除标准
- •Exclusion Criteria for all patients at registration
- •? Pregnant or lactating women
- •? Actively bleeding tumor if the patient is intended to be treated with carboplatin
- •? Cardiac abnormalities as demonstrated by
- •- recent history of congestive heart failure
- •- unstable angina within the past 3 months
- •- cardiac arrhythmia
- •- myocardial infarction
- •- history of prolonged QT interval or intake of medications that have risk for QT prolongation
- •- TIA within the past 6 months;
- •? Previous cardiac toxicity induced by another anthracycline or previous exposure to maximum cumulative dose of another anthracycline if the patient is intended to be treated with doxorubicin
- •? History of allergic reactions attributed to compounds of similar chemical or biological composition to cis/carboplatin, paclitaxel, doxorubicin, bicalutamide or triptorelin
- •? Concomitant medications with terfenadine, astemizole, cisaprid
- •? Use of phenytoin
- •? Active second malignancy during the last five years except nonmelanoma skin cancer or carcinoma in situ of the cervix;
- •? Patients with bone disease or brain disease as the sole disease site are excluded; brain metastases are allowed in the case of systemic disease, but must have been treated at least 4 weeks before enrollment and must be stable thereafter;
- •? Patients who received vaccine for yellow fever are not eligible
- •? Patients with an immediate family member (e.g. spouse, parent/legal guardian, sibling or child) who is in investigational site or Sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific subject.
研究者
相似试验
进行中（未招募）
1 期
A randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs)Salivary gland cancerMedDRA version: 17.0Level: PTClassification code 10061934Term: Salivary gland cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-000314-38-FREuropean Organisation for Research and Treatment of Cancer (EORTC)452
进行中（未招募）
1 期
A randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs)Salivary gland cancerMedDRA version: 20.0Level: PTClassification code 10061934Term: Salivary gland cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-000314-38-BEEuropean Organisation for Research and Treatment of Cancer (EORTC)220
进行中（未招募）
1 期
A randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs)EUCTR2013-000314-38-NLEuropean Organisation for Research and Treatment of Cancer (EORTC)220
招募中
2 期
A randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs)salivary duct carcinoma10072990NL-OMON54823European Organisation for Research in Treatment of Cancer (EORTC)1
进行中（未招募）
1 期
A randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs)Salivary gland cancerMedDRA version: 19.0Level: PTClassification code 10061934Term: Salivary gland cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-000314-38-HUEuropean Organisation for Research and Treatment of Cancer (EORTC)452