EUCTR2007-006682-33-CZ进行中（未招募）不适用
Randomzied Phase 2 Trial of AG-013736 or Bevacizumab in Combination with Paclitaxel and Carboplatin as First Line Treatment For Patients with Advanced Non-small Cell Lung Cancer
Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA0 个研究点目标入组 108 人开始时间: 2008年3月19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
- 108
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 diagnosis of advanced non-squamous cell,
- •NSCLC with documented Stage IIIB with pleural effusion, or Stage IV or recurrent
- •2. At least one site of measurable disease (per RECIST). Measurable disease that has been previously irradiated will not be considered a target lesion unless the lesion diameter has grown by =20 % since completion of the prior radiation therapy or if the lesion is a new lesion, assuming all other criteria are met.
- •3. No prior systemic treatment for NSCLC except prior adjuvant/neo-adjuvant therapy if last dose was >12 months prior to enrollment.
- •4. Adequate organ function as determined by the following criteria:
- •Absolute neutrophil count (ANC) =1500 cells/mm3;
- •Platelet count =100,000 cells/mm3;
- •Hemoglobin =9 g/dL;
- •Serum creatinine =1.5 x upper limit of normal (ULN) or calculated creatinine clearance =60 mL/min;
- •AST and ALT <2.5 x ULN, or AST and ALT <5 x ULN if liver function abnormalities are due to underlying malignancy;
- •Total bilirubin =1.5 x ULN;
- •Urine protein:creatinine ratio <0.5.
- •5. Age =18 years.
- •6. ECOG performance status of 0 or 1.
- •7. Life expectancy >12 weeks.
- •8. Prior surgery or radiation therapy is permitted. Radiation therapy must have completed
- •=21 days or major surgery =28 days prior to start of treatment. All acute toxicities must have resolved to baseline or to CTC Grade 1 (NCI CTCAE v3.0). Fine needle aspiration procedures (if necessary) must have been completed =7 days prior to treatment.
- •9. Female patients may not be pregnant or breastfeeding. Female patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving study treatment and for at least 6 months thereafter.
- •10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of patient reported outcome measures.
- •11. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial before enrollment
- •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. Histologic evidence of predominantly squamous-cell NSCLC.
- •2. Prior treatment with systemic therapy for advanced disease.
- •3. Prior treatment with a VEGF or VEGFR inhibitor.
- •4. Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be =140 mm Hg, and the baseline diastolic blood pressure readings must be =90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
- •5. Known central nervous system (CNS) metastasis. CNS imaging at baseline is required.
- •6. Current or recent (within 1 month) use of a thrombolytic agent.
- •7. History of a hematologic diathesis or coagulopathy within 6 months of study entry
- •8. Need for therapeutic anticoagulation (at time of screening).
- •9. Ongoing or recent (within 10 days prior to treatment start) need for full therapeutic dose of oral or parenteral anticoagulant or chronic daily treatment with aspirin (>325 mg/day)
- •or clopidogrel (>75 mg/day).
- •10. History of hemoptysis =½ tsp of bright red blood per day within 4 weeks of enrollment.
- •11. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism.
- •12. Gastrointestinal abnormalities including:
- •Inability to take oral medication;
- •Requirement for intravenous alimentation;
- •Prior surgical procedures affecting absorption including gastric resection;
- •Treatment for active peptic ulcer disease in the past 6 months;
- •Active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis,
- •hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
- •Malabsorption syndromes.
- •13. Active, invasive malignancies other than NSCLC:
- •The patient may not have radiographic or clinical signs of another cancer, and must
- •not be getting any form of treatment for cancer.
- •14. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, itraconazole, erythromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, and delavirdine) is not permitted.
- •15. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, and St. John’s wort) is not permitted. (Note: The short-term use of dexamethasone as a premedication for chemotherapy is not an exclusion criterion).
- •16. Acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
研究者
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