PER-110-08已完成未知
A phase II Biomarker Identification Trial for Erlotinib (Tarceva) in Patients with Advanced Pancreatic Carcinoma. - ND
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 100（—）
入选标准
- •Patients with locally advanced pancreatic cancer, not removable or metastatic, histologically or cytologically confirmed in which the tumor is accessed for biopsy
- •Quantifiable disease according to the RECIST criteria (irradiated lesions cannot be used as reference lesions)
- •Failure of a previous chemotherapy regimen as a minimum, or patients considered unfit for chemotherapy according to the researchers´ criteria. It should have been> 4 weeks since the last chemotherapy or treatment with another systemic antineoplastic. Patients must have recovered (CTC = 1) from acute toxicities caused by some previous therapy (except alopecia).
- •Patients may have received prior radiotherapy for treatment of the local disease, provided that disease progression has been documented, all toxicities have been resolved (CTC = 1) (except for alopecia), and the last radiotherapy fraction is completed at least 4 weeks before randomization.
- •Life expectancy> 6 weeks
- •Age> 18 years
- •Functional status (PS) according to the O-2 ECOG (see section 5.3.2)
- •Ability to comply with the protocol
- •Written informed consent (signed) by to participate in the study
- •The patient must have the will and be able to undergo a biopsy according to their own guidelines and the institution´s requirements for such a procedure.
- •Adequate hematological function: ANC = 1.5 x 10 / liter, platelet count = 100 X 10 / liter and Hb = 9 g / dl
- •INR = 1.5 and PTT = 1.5 x ULN within 7 days prior to randomization
- •Platelet aggregation inhibitors should be discontinued within an appropriate period of time before biopsy
- •Adequate liver function: serum bilirubin (total) = 1.5 x ULN, SGOT (AST) and SGPT (ALT) <2.5 X ULN in the absence of liver metastases or up to 5 x ULN for SGOT (AST) and SGPT ( ALT) in case of liver metastases,
- •Albumin> 2.5 g / dl
- •Adequate renal function: serum creatinine <1.5 ULN
- •In all women of childbearing age, a negative pregnancy test must be obtained within 7 days prior to beginning treatment.
排除标准
- •Patients with local pancreatic cancer (stage IA to IIB) and excised locally advanced pancreatic cancer.
- •Previous treatment with a research or commercialized agent acting on the EGFR axis. EGFR inhibitors include (but are not limited to) erlotinib, gefitinib or other anti-EGFR or EGF monoclonal antibody therapies or double TK1 inhibitors
- •Any other malignancy that had occurred within the last 5 years prior to randomization, except for properly treated cervical carcinoma in the cervix, basal cell or spinocellular skin cancer
- •Evidence of spinal cord compression or current evidence of CNS metastases. A computed tomography / MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of clinical suspicion or evidence of brain metastases
- •Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease such as stroke (<6 months before randomization), myocardial infarction (= 6 months before randomization) , unstable angina, CHF> grade 2 according to NYHA, arrhythmia requiring medication, liver, kidney or metabolic disease, metabolic dysfunction), physical examination observation, or clinical laboratory finding that indicates reasonable suspicion of a disease or condition that contraindicates the use of a drug under investigation or that constitutes a high risk of complications related to the treatment for the patient
- •Patients who had undergone major surgery within 2 weeks prior to randomization.
- •Any known significant ophthalmic abnormality on the surface of the eye (contact lens wear is not recommended)
- •Patients who cannot take oral medication, that require intravenous feeding, who have malabsorption syndrome or any other condition that affects gastrointestinal absorption, or who have active peptic ulcer
- •Pregnant or breastfeeding women
- •Men and women of childbearing age (<2 years after the last menstrual period) who are not using an effective contraceptive method (eg, oral contraceptives, intrauterine device, sexual abstinence or surgical sterilization), having a rate of effectiveness as a value of failure <1% / year.
- •Current or recent treatment (within 30 days prior to beginning the study treatment) with another investigational drug or participation in another research study
- •Patients with known positive HIV. No analysis is required in the absence of clinical signs and symptoms that suggest HIV infection.
- •Known hypersensitivity to any of the study drugs or their excipients.
研究者
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