EUCTR2010-018850-11-DE进行中（未招募）不适用
Panitumumab in combination with cisplatin/gemcitabine chemotherapy in patients with cholangiocarcinomas - a randomized clinical phase II study - PiCCA Study - PiCCA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- Female
入选标准
- •Signed and dated informed consent before the start of specific protocol procedures.
- •Histologically or cytologically documented diagnosis of cholangiocarcinoma or gall bladder carcinoma
- •Presence of at least one measurable site of disease following RECIST V. 1.1 criteria
- •Wild-type KRAS status as assessed by standardized PCR
- •Unresectable, locally advanced or metastatic disease
- •Age > 18 years.
- •ECOG Performance Status of 0 or 1
- •Life expectancy of at least 12 weeks.
- •Adequate bone marrow, liver (with stenting for any obstruction, if required) and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •-Hemoglobin > 10.0 g/dl
- •-Leukocyte count >3.000/mm3 ; absolute neutrophil count (ANC) >1.500/mm3
- •-Platelet count >= 100.000/mm³
- •-Total bilirubin < 5,0 times the upper limit of normal
- •-ALT and AST < 3 x upper limit of normal
- •-Alkaline phosphatase < 5 x ULN
- •-PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
- •-Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 60 ml/min.
- •-Magnesium = lower limit of normal; calcium = lower limit of normal
- •The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
- •Negative pregnancy test performed within 7 days of the start of treatment, and willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 92
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 92
排除标准
- •KRAS mutation
- •Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrolment.
- •History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •History of HIV infection or chronic hepatitis B
- •Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- •Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex
- •Symptomatic or known brain metastases. A scan to confirm the absence of brain metastases is not required.
- •Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •History of organ allograft
- •Patients with evidence or history of bleeding diathesis
- •Patients undergoing renal dialysis
- •Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix
- •Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •Excluded therapies and medications, previous and concomitant:
- •No prior anti-cancer chemotherapy, radiotherapy (excluding palliative radiotherapy administered more than 4 weeks prior to study entry), endocrine or immunotherapy.
- •Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- •Major surgery within 4 weeks of starting the study and patients must have recovered from effects of major surgery
- •Prior anti-EGFR therapy
- •Autologous bone marrow transplant or stem cell rescue within 4 months of study
- •Breast-feeding patients
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient’s understanding of the informed consent procedure, participation in the study or evaluation of the study results.
研究者
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