CTRI/2008/091/000128已完成2 期
A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients with Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer.
Peregrine Pharmaceuticals, Inc0 个研究点目标入组 49 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
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
入选标准
- •1. Written informed consent has been obtained
- •2. Adults over age 18 years of age with a life expectancy of at least 3 months
- •3. Histologically confirmed stage IIIB (with pleural effusion), stage IV, or recurrent non-small cell lung cancer
- •4. Measurable disease on cross sectional imaging that is at least 2 cm in longest diameter (1 cm if measured by spiral CT)
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- •6. Adequate hematologic function (Absolute Neutrophil Count (ANC) ≥ 1,500 cells/µL; Hemoglobin > 9 g/dL, platelets > 100,000/µL and ≤ 500,000/µL)
- •7. Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min)
- •8. Adequate hepatic function (bilirubin ≤ 1.5 x ULN, alanine amino transferase (ALT) ≤ 3 x ULN, aspartate amino transferase (AST) ≤ 3 x ULN)
- •9. Prothrombin time / international normalized ratio within institutional normal limits
- •10. Activated partial thromboplastin time ≤ 1.5 ULN
- •11. D-dimer ≤ 2 x ULN
- •12. New York Heart Association classification I or II
- •13. Female patients must have a negative serum pregnancy test at prestudy (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
排除标准
- •1. Prior exposure to any chimeric antibody
- •2. Small cell or mixed histology
- •3. Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
- •4. Any current evidence (or history in 12 months) of clinically significant bleeding defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
- •5. Any history of thromboembolic events in the last 12 months [e.g., deep vein thrombosis (DVT) or pulmonary thromboembolism (PE)] including central venous catheter-related thrombosis
- •6. Ongoing therapy with oral or parenteral anticoagulants; patients on low dose anticoagulants to maintain patency of lines are eligible
- •7. Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen)
- •8. Significant peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
- •9. Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
- •10. Radiotherapy within 2 weeks preceding Study Day 1
- •11. Symptomatic or clinically active CNS
- •12. Major surgery within 4 weeks of Study Day 1
- •13. Pregnant or nursing women
- •14. All patients of reproductive potential must agree to use an approved form of barrier contraception
- •15. Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
- •16. Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
- •17. Cardiac arrhythmia requiring medical therapy
- •18. A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin
- •19. Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture)
- •20. Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs (e.g., phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), or steroids
- •21. Known chronic infection with HIV or viral hepatitis
研究者
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