EUCTR2007-003738-40-BG进行中（未招募）不适用
A phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients with Advanced Pancreatic Carcinoma - MARK
F. Hoffmann-La Roche0 个研究点目标入组 200 人开始时间: 2008年8月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •1. Histologically or cytologically confirmed locally advanced-unresectable or metastatic pancreatic cancer
- •2. Measurable disease according to RECIST (irradiated lesions can not be used as target lesions)
- •3. Failure of at least one prior chemotherapy regimen or patients who are deemed unsuitable for chemotherapy in the investigators opinion. >= 4 weeks since last chemotherapy or treatment with another systemic anti-cancer agent. Patients must have recovered (CTC <= 1) from acute toxicities of any previous therapy (with the exception of alopecia).
- •4. Patients may have received prior radiotherapy for management of local disease providing that disease progression has been documented, all toxicities have resolved (CTC <= 1) (with the exception of alopecia), and the last fraction of radiotherapy was completed at least 4 weeks prior to randomization.
- •5. Life expectancy of = 6 week
- •6. Age >= 18 years
- •7. ECOG performance status of 0 - 1 (see section 5.3.2)
- •8. Able to comply with the protocol
- •9. Written (signed) Informed Consent to participate in the study
- •10. Patient must be willing and able to undergo biopsy according to the institute’s own guidelines and requirements for such procedures.
- •11. Adequate hematological function: ANC >= 1.5 x 109/L, platelet count >= 100 x 109/L and Hb >= 9 g/dL
- •12. INR <= 1.5 and PTT <=1.5 x ULN within 7 days prior to randomization
- •13. Platelet aggregation inhibitors must discontinued within an appropriate time period before biopsy
- •14. Adequate liver function: Serum (total) bilirubin <= 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 in case of liver metastases,
- •15. Albumin >= 2.5 g/dL
- •16. Adequate renal function: serum creatinine < 1.5 ULN
- •17. Normal serum calcium
- •18. For all females of childbearing potential a negative pregnancy test must be obtained within 7 days before start of treatment.
- •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
- •1. Local (Stage IA to IIB) pancreatic cancer and locally advanced-resectable pancreatic cancer.
- •2. Prior treatment with an investigational or marketed agent which acts on the EGFR axis. EGFR inhibitors include (but are not limited to) erlotinib, gefitinib or other anti-EGFR or EGF monoclonal antibody therapy or dual TKI inhibitors
- •3. Any other malignancies within the last 5 years before study start, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer
- •4. Evidence of spinal cord compression or current evidence of CNS metastases. CT/MRI of the brain is mandatory (within 4 weeks before study start) in case of clinical suspicion or evidence of brain metastases
- •5. Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease for example CVA (<= 6 months before study start), myocardial infarction (<= 6 months before study start), unstable angina, NYHA >= grade 2 CHF, arrhythmia requiring medication, hepatic, renal or metabolic disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
- •6. Patients who have had any major surgery within 2 weeks prior to study start
- •7. Any known significant ophthalmologic abnormalities of the surface of the eye (the use of contact lenses is not recommended)
- •8. Patients unable to take oral medication, requiring intravenous alimentation, who have mal-absorption syndrome or any other conditions affecting gastrointestinal absorption, or who have active peptic ulcer disease
- •9. Pregnant or lactating females
- •10. Men and women of childbearing potential (<2 years after last menstruation) not using effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile)
- •11. Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study
- •12. Patients known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection.
- •13. Patients using coumadin or warfarin
- •14. Known hypersensitivity to any of the study drugs or their excipients.
研究者
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