EUCTR2006-005970-26-DE进行中（未招募）不适用
A Randomized (Phase II), Double-blind, Multicenter Phase I/II trial of Pemetrexed, Carboplatin plus or minus Sorafenib in the First-line Treatment of Patients with Stage IIIb or IV Non-Small Cell Lung Cancer - PECASO
niversitätsklinikum Münster0 个研究点开始时间: 2007年1月11日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Histologically or cytologically confirmed NSCLC
- •Locally advanced (stage IIIB with malignant pleural or pericardial effusion)
- •or metastatic (stage IV) NSCLC
- •No prior systemic chemotherapy
- •Prior local radiotherapy is allowed if it is completed at least 3 weeks prior
- •to the first dose of study medication; also concomitant palliative
- •radiotherapy to an existing bone lesion for pain control is allowed
- •Prior surgery is allowed if it is performed at least 4 weeks prior to the first
- •dose of study medication and patient should be fully recovered.
- •Must have measurable disease with at least one lesion with a longest
- •diameter measured as = 2 cm with conventional techniques or as = 1 cm
- •with spiral CT
- •Age =18 years old
- •ECOG performance score (PS) 0-1
- •Life expectancy of at least 12 weeks
- •Adequate bone marrow, renal and hepatic function
- •ohemoglobin = 9.0 g/dl
- •oabsolute neutrophil count =1,500/mm3
- •oplatelet count = 100,000/mm3
- •ototal bilirubin = 1.5 times the upper limit of normal
- •oALT and AST = 2.5 times the upper limit of normal (= 5 x upper limit of
- •normal for patients with liver involvement)
- •oINR = 1.5 and aPTT within normal limits
- •oserum creatinine = 1.5 the upper limit of normal
- •Patients with creatinine clearance = 45 mL/min
- •Not pregnant or nursing patients
- •Women of childbearing potential must have a negative serum pregnancy
- •test performed within 7 days prior to the start of treatment
- •Women of childbearing potential and men must agree to use adequate
- •contraception (barrier method of birth control) prior to study entry and for
- •the duration of study participation. Men should use adequate birth control
- •for at least six months after the last administration of sorafenib
- •Signed informed consent prior to any study specific procedures
- •Estimated life expectancy of at least 12 weeks.
- •Compliance and geographic proximity that allow adequate follow-up.
- •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
- •Any prior systemic anticancer therapy including cytotoxic therapy, targeted
- •agents, experimental therapy (treatment within the last 30 days with a
- •drug that has not received regulatory approval for any indication at the
- •time of study enrollment), adjuvant, or neo-adjuvant therapy for NSCLC
- •Any participation in a clinical trial 30 days prior to study entry and
- •concomitantly to the study
- •Cardiac disease: Congestive heart failure > class II NYHA. Patients must
- •not have unstable angina (angina symptoms at rest) or new-onset angina
- •(began within the last 3 months) or myocardial infarction within the past 6
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mm
- •Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
- •Documented brain metastases (unless the patient has completed
- •successful local therapy for brain metastases and has been off
- •corticosteroids for at least 4 weeks before study enrolment). Brain imaging
- •(CT scan/MRI) is required in symptomatic patients to rule out brain
- •metastases, but is not required in asymptomatic patients.
- •Known HIV infection or chronic hepatitis B or C
- •Active clinically serious infections > CTCAE Grade 2
- •Presence of clinically significant third-space fluid collections (for example,
- •ascites or pleural effusions) that cannot be controlled by drainage or other
- •procedures prior to study enrolment.
- •Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks
- •of first dose of study drug
- •Any other hemorrhage/bleeding event > =Grade 3 within 4 weeks of first
- •dose of study drug
- •Evidence or history of bleeding diathesis or coagulopathy
- •Therapeutic anticoagulation with vitamin K antagonists such as
- •phenprocoumon, warfarin, or with heparins or heparinoids. Low dose
- •anticoagulation is permitted
- •Serious, non-healing wound, ulcer, or bone fracture
- •Major surgery, open biopsy or significant traumatic injury within 4 weeks
- •of first dose of study drug
- •Known or suspected allergy to sorafenib, carboplatin or pemetrexed
- •Previous or current cancer that is distinct in primary site or histology from
- •NSCLC except cervical cancer in-situ, treated basal cell carcinoma,
- •superficial bladder tumors (Ta and Tis) or any cancer curatively treated > 3
- •years prior to study entry
- •Substance abuse, medical, psychological or social conditions that may
- •interfere with the patients participation in the study
- •Significant weight loss (> or equal 10% body weight during preceeding 6
- •Inability to interrupt aspirin or other nonsteroidal anti-inflammatory
- •agents, other than an aspirin dose = 1.3 grams per day, for a 5-day period
- •(8-day period for long-acting agents, such as piroxicam).
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation.
- •Recent (within 30 days of enrolment) or concurrent yellow fever vaccination
- •Serious concomitant systemic disorder that, in the opinion of the
- •investigator, would compromise the patient’s a
研究者
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