EUCTR2005-000053-30-BE进行中（未招募）不适用
A randomized phase 2 study of the anti-angiogenesis agent AG-013736 in combination with gemcitabine in patients with chemotherapy-naïve advanced pancreatic cancer preceded by a phase 1 portion
Pfizer Inc. - La Jolla laboratories0 个研究点目标入组 102 人开始时间: 2005年7月5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
- 102
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. patients with advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas
- •2. no prior therapy for metastatic disease
- •3. no adjuvant chemotherapy within the 4 weeks before registration (Phase 1) or randomization (Phase 2) (patient must have recovered from all treatment-related toxicities and must have evidence of disease progression following adjuvant treatment)
- •4. no radiotherapy within the 4 weeks before registration (Phase 1) or randomization (Phase 2) (patient must have recovered from all treatment-related toxicities and must have evidence of disease progression following treatment. Prior radiotherapy [with or without fluoropyrimidines for radiosensitization] is allowed provided the patient has disease outside the radiation port)
- •5. adequate bone marrow function as defined by:
- •- ANC =1500 cells/mm3
- •- platelets =100, 000 cells/mm3
- •- hemoglobin =9 g/dL (which may be obtained by transfusion or growth factor support)
- •6. adequate liver function as defined by:
- •- bilirubin =1.5 times upper limit of normal (x ULN)
- •- AST and ALT =2.5 x ULN
- •7. adequate renal function as defined by both:
- •- serum creatinine =1.5 x ULN
- •- =500 mg urinary protein/24 hours or dipstick <2+
- •8. no evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart on the same day (The baseline systolic blood pressure readings must be less than or equal to 140 mm Hg, and the baseline diastolic blood pressure readings must be less than or equal to 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible)
- •9. ECOG performance status of 0, 1, or 2 (See Appendix 1)
- •10. life expectancy ?12 weeks
- •11. adults =18 years of age
- •12. negative serum or urine pregnancy test for women of child-bearing potential
- •13. evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the trialpatients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
- •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. prior treatment with gemcitabine, VEGF/VEGFR inhibitors, or anti-angiogenesis treatment of any kind in the adjuvant setting.
- •2. patients with locally advanced disease who are candidates for radiation therapy.
- •3. current use or anticipated need for drugs that are known CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, ergot derivatives, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, and delavirdine) during the course of study
- •4. current use or anticipated need for drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, and St John’s wort) during the course of study
- •5. requirement of anticoagulant therapy except for low-dose anticoagulants for maintenance of patency of central venous access or prevention of deep vein thrombosis (DVT)
- •6. uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)
- •7. inability to take oral medications
- •8. history of hemorrhagic or thrombotic cerebrovascular event in the past 12 months
- •9. major surgical procedure within 4 weeks of treatment for Phase 1 or randomization for Phase 2
- •10. unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with achievement of study objectives
- •11. psychological or sociological conditions, addictive disorders, or family problems, which would preclude compliance with the protocol
- •12. history of a malignancy (other than pancreatic cancer) except those patients treated with curative intent for skin cancer (other than melanoma) or in situ cervical cancer or those treated with curative intent for any other cancer with no evidence of disease
- •13. patients having procreative potential who are not using adequate contraception or practicing abstinence
- •14. women who are pregnant or breast-feeding
- •15. patients with proteinuria. (Patients with >1+ protein on urine dipstick at baseline should undergo a 24-hour urine collection. Results must demonstrate =500 mg of protein in 24 hours to allow participation in the study.
- •16. other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial
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