DRKS00003516招募中2 期
An open-label, randomised, multicentre, phase II study to evaluate the efficacy of chemotherapy with gemcitabine and cisplatin in combination with the EGF receptor antibody panitumumab (GemCisP) versus GemCis in the first-line therapy of locally advanced/metastatic urothelial carcinoma in patients with wild-type HRAS - PURO - AB 23/09 - PURO
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH0 个研究点目标入组 124 人开始时间: 2012年4月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 124
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
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 99 Years（—）
- 性别
- All
入选标准
- •Histologically or cytologically confirmed, unresectable urothelial carcinoma of the bladder or the upper urinary tract
- •- Wild-type HRAS
- •- Male and female subjects > 18 years of age
- •- General condition ECOG 0-1
- •- Life expectancy at least 12 weeks
- •- Women of child-bearing potential: negative pregnancy test and use of effective contraception(oral contraceptive, coil); men: use of adequate male contraception (condom) for up to 3 months after discontinuation of panitumumab therapy
- •- Locally advanced or metastatic disease (T3b,T4 and/or N+ and/or M+)
- •- At least one unidimensionally measurable lesion detectable in CT or MRI corresponding to the RECIST criteria
- •- Adequate haematological, hepatic, renal and metabolic function parameters:
- •Leukocytes > 3000/mm³, ANC = 1500/mm³, platelets = 100,000/mm³, hemoglobin > 9 g/dl, Creatinine clearance = 50 ml/min and serum creatinine = 1.5 x upper limit of normal, Bilirubin = 1.5 x upper limit of normal, GOT-GPT = 2.5 x upper limit of normal in absence of liver metastases, or = 5 x upper limit of normal in presence of liver metastases, AP = 5 x upper limit of normal, Magnesium = lower limit of normal; calcium = lower limit of normal, INR and PTT < 1.5 x the upper limit of the normal reference range
排除标准
- •- HRAS mutation
- •- Absence of any of the above-listed inclusion criteria
- •- Dialysis-dependence following nephrectomy
- •- Patients with cerebral tumours and/or cerebral metastases
- •- Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrolment.
- •- Patients with uncontrolled hypertension; systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical treatment
- •- History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •- Patients with thrombotic or embolic events, such as stroke or pulmonary embolism
- •- Patients with recent or known history of haemorrhagic diathesis
- •- Known significant neurological or psychiatric disorders, including dementia and epileptic seizures
- •- Serious inflammatory eye conditions, hearing impairment
- •- Pulmonary (pO2 < 60 mmHg), haemopoietic (e.g. serious bone marrow aplasia), hepatic or renal disorders
- •- Patients with poorly controlled diabetes mellitus
- •- Serious bacterial or fungal infections (>grade 2 NCI CTC Version 3)
- •- Chronic hepatitis B or C; HIV infection
- •- Autoimmune disease
- •- Allergic reaction to one of the medications to be used
- •- Status post organ transplantation
- •- Status post autologous bone marrow transplantation or stem cell transplantation in the 4 months prior to study commencement
- •- Manifest secondary malignancy or other form of cancer in the previous 5 years (excluding basalioma, in situ cervical cancer, incidental prostatic cancer)
- •- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
- •- Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 3 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
- •- Active participation in other clinical studies in the previous 4 weeks
- •- Prior systemic therapy with cytostatics or immunotherapeutic agents
- •- Concurrent use of other anticancer treatments after study commencement
- •- Intravesical chemotherapy in the previous 4 weeks
- •- Radiotherapy in the previous 4 weeks
- •- Previous radiotherapy in which all lesions to be used for the evaluation of tumour response were irradiated
- •- Patients in a closed institution according to an authority or court decision
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