EUCTR2014-000857-35-IT进行中（未招募）1 期
An open label, randomized, phase 2 study of Paclitaxel and Panitumumab compared to Paclitaxel alone in patients with relapsed or refractory urothelial cancer. - Anti EGFR therapy in relapsed/refractory urothelial carcinoma.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- •Histologically confirmed diagnosis of transitional cell tumors of the bladder or the urothelium. Presence of divergent histologies (i.e. squamous-cell tumor, adenocarcinoma, small cell carcinoma, micropapillary variant) may be acceptable provided that there is prevalence (> 50%) of urothelial component.
- •Locally advanced or metastatic disease.
- •Age =18 and =75.
- •Measurable disease criteria, defined as =1 unidimensionally measurable lesion =2 cm by conventional techniques or =1 cm by spiral CT scan.
- •Failure (i.e. disease relapse/progression by RECIST v1.1 criteria) of one or two platinum-based (either cisplatin or carboplatin) conventional chemotherapy regimen for metastatic disease (second and third-line setting will be the objective of this study).
- •Neoadjuvant/adjuvant therapy will be counted as one prior chemotherapy line if relapse has occurred within 6 months of the last cycle of chemotherapy.
- •Female subject is either:
- •opost-menopausal for at least one year before the screening visit, or
- •o surgically sterilized, or
- •owilling to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 2 months following the last dose of panitumumab.
- •Male subject, even if surgically sterilized (ie, status postvasectomy), agrees to use an acceptable method for contraception during the entire study treatment period through 2 months after the last dose of panitumumab.
- •Absolute neutrophil count (ANC) >1,500/mm³, platelets >100,000/mm³, Hgb >9 g/dL. Values must be obtained without need for myeloid growth factor or platelet transfusion support within 14 days, however, erythrocyte growth factor is allowed as per published ASCO guidelines.
- •Total bilirubin =1.5 x upper limit of nomal (ULN), SGOT (AST) and SGPT (ALT)< 2.5 x ULN. AST and/or ALT may be up to 5X ULN if with known liver mets.
- •Adequate renal function as defined by: Calculated creatinine clearance must be =30 mL/minute.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 & life expectancy of at least 12 weeks.
- •Patients must be accessible for treatment and follow up as well as they must be willing and capable to comply with the requirements of the study.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is considered to be over 25%.
- •Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen.
- •Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids or H2 antagonists are allowed.
- •Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection.
- •Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- •Presence of interstitial pneumonitis, pulmonary fibrosis, evidence of interstitial pneumonitis, or pulmonary fibrosis.
- •Female subject who is either pregnant or breast-feeding or planning to become pregnant during treatment and within 2 months of the last dose of panitumumab. Confirmation that the subject is not pregnant must be established by a negative serum ?-human chorionic gonadotropin (?-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- •Patient has received other investigational drugs with 14 days before enrollment
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •Other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study.
- •Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- •Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion. For guidance in defining active infection for hepatitis B, please refer to the WHO guidelines. (World Health Organization, Global Alert and Response (GAR), Hepatitis B. who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index4.html)
- •Prior administration of an anti EGFR-targeted agent, including but not limited to panitumumab.
- •Administration of myeloid growth factors or platelet transfusion within 14 days prior to the first dose of study treatment.
- •Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
研究者
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