EUCTR2008-007799-13-AT进行中（未招募）不适用
Panitumumab and Pegylated Liposomal Doxorubicin to Platinum-Resistant Epithelial Ovarian Cancer with KRAS Wild-type - AGO 22 - PaLiDo
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 33
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
- •Histological confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer stage I-IV.
- •A: First line treatment with first line chemotherapy with a platinum-based regimen with either progression or no response during 1.line chemotherapy, or relapse within 6 months after end of 1. line chemotherapy.
- •B: Patients receiving second line with a platinum-based regimen with either progression
- •or no response during second line chemotherapy, or relapse within 6 months after end
- •of second line chemotherapy.
- •Maximum two prior lines of chemotherapy (both platinum-based).
- •Age = 18 years.
- •Performance status 0-2.
- •Measurable disease by CA125 GCIG criteria’s (evaluation of response according to CA 125 is used in this protocol).
- •KRAS wild type.
- •Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to enrollment):
- •WBC = 3.0 x 109/l or neutrophils (ANC) = 1.5 x 109/l
- •Platelet count = 100 x 109/l
- •Hemoglobin = 9.7 g/dl (6 mmol/L)
- •Serum bilirubin = 1.5 x UNL
- •Serum transaminases = 2.5 x UNL in absence of liver metastases, or =5xUNL in
- •presence of liver metastases
- •Serum creatinine = 1.5 x UNL
- •Magnesium = lower limit of normal
- •Calcium = lower limit of normal
- •Written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior treatment with chemotherapy or biological targeted treatment except 1. or 2. line chemotherapy with platinum or combination platinum/taxane (bevacizumab allowed as part of the 1. line treatment).
- •Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days
- •prior to entering this trial.
- •Pregnant or breast-feeding or planning to become pregnant within 6 months after end of treatment. For fertile women a negative pregnancy test at screening is mandatory.
- •Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months following treatment.
- •Other present or previous malignancy except curatively treated cervical cancer, non-melanotic skin cancer or other cancer with minimal risk of relapse.
- •CNS metastasis.
- •History of any chronic medical or psychiatric condition or laboratory abnormality that are not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration (e.g. diabetes, cardiac diseases, hypertension).
- •Clinically significant cardiovascular disease = 1 year before enrollment/randomization, including:
- •-Myocardial infarction or unstable angina within 6
- •months of randomization.
- •-New York Heart Association (NYHA) = Grade 2
- •congestive heart failure. Even if medically controlled.
- •-Poorly controlled cardiac arrhythmia despite medication (patients with rate- controlled atrial fibrillation are eligible).
- •Uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed).
- •Allergy to the ingredients of the study medication or to Staphylococcus Protein A.
- •History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
研究者
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