Phase I Feasibility Study of the Combination of Fondaparinux (Arixtra) With Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- The tolerability and safety of the combination of fondaparinux with standard chemotherapy (carboplatin/paclitaxel).
研究概览
简要总结
There is a direct association between cancer and thrombosis (blood clots). The purpose of this study is to determine the best dose of an antithrombotic (prevents blood clots) agent called fondaparinux in non-small cell lung cancer(NSCLC). Patients will also receive chemotherapy.
详细描述
This is a single center, open-labeled, single arm phase 1 feasibility study in patients with newly diagnosed stage IV NSCLC. To evaluate the change in the biologic parameters measured, two cohorts of patients will receive altered dosing regimens of fondaparinux starting with the second cycle of chemotherapy. The biologic parameters measured during the first cycle of chemotherapy will serve as a control for each patient. Chemotherapy consists of 3-week cycles of carboplatin and paclitaxel. The absolute maximum length of therapy with fondaparinux will be 3 months, regardless of which cohort the patient is assigned.
This study consists of 2 cohorts:
Cohort 1:
Patients in cohort 1 will receive standard chemotherapy alone during cycle 1. During subsequent cycles (2-4) patients will receive a daily prophylactic dose (day 1 through 21) of fondaparinux. The anticoagulation will continue 21 days after the last course of chemotherapy.
Cohort 2:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of Non-Small Cell Lung Cancer.
- •Stage IV Non-Small Cell Lung Cancer.
- •Measurable or assessable tumor parameters according to RECIST criteria.
- •ECOG Performance Status 0-
- •Age between 18 and 79 years (in the State of Alabama > 18).
- •Adequate hematologic, coagulation, liver and renal function, defined as:
- •Absolute neutrophil count (ANC) ≥ 1500/µL
- •Platelet count ≥ 100,000/µL
- •Serum Glutamic Oxaloacetic Transaminase(SGOT)/Serum Glutamic Pyruvic Transaminase(SGPT) ≤ 2.5 x upper limit of normal or ≤ 5 x upper limit of normal when liver metastases are present
- •Total bilirubin value ≤ 1.5 x upper limit of normal
- •Serum creatinine value ≤ 1.5 x upper limit of normal
- •Normal prothrombin time and partial thromboplastin time
- •Fully recovered from any previous surgery (at least 4 weeks since major surgery).
- •Must have recovered from prior radiation therapy (at least 3 weeks).
- •All participants must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential.
- •Must provide written informed consent and authorization to use and disclose health information.
- •No prior chemotherapy.
排除标准
- •Active bleeding disorder.
- •Evidence of hemoptysis. Patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 mL of blood per episode and less than 10 mL of blood per 24-hour period in the best estimate of the investigator.
- •Previous history of Venous Thromboembolism (VTE) within 12 months and requiring active anticoagulation therapy.
- •Concurrent cancer chemotherapy, biologic therapy or radiotherapy.
- •Administration of any investigational drug within 28 days prior to administration of the current therapy.
- •Symptomatic brain metastases; those patients should be treated first with either whole brain radiation therapy or radiosurgery and have stable disease.
- •Concurrent serious infection.
- •Concomitant severe or uncontrolled underlying medical disease unrelated to the tumor, which is likely to compromise patient safety and affect the outcome of the study.
- •History of other malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for a minimum of 2 years.
- •Any evidence or history of hypersensitivity or other contraindications for the drugs used in this trial.
- •Psychiatric disorder that prevents patients from providing informed consent or following protocol instructions.
- •Pregnant or lactating women.
- •Creatinine clearance < 30 mL/min.
- •Patient body weight < 50 kg.
研究组 & 干预措施
Combination of Arixtra with chemotherapy
Carboplatin 6 AUC q 21 days; Paclitaxel 200 mg/m2 q 21 days. Cohort I: Arixtra 2.5 mg SQ qd x 21 days; Cohort II: Arixtra weight-based dose (D1-2)followed by Arixtra 2.5 SQ q day (D3-21)
干预措施: Combination of Arixtra with chemotherapy (Drug)
结局指标
主要结局
The tolerability and safety of the combination of fondaparinux with standard chemotherapy (carboplatin/paclitaxel).
时间窗: Every 3 weeks prior to each cycle of therapy.
次要结局
- Clinically evident Venous Thromboembolism (VTE)(Every 3 weeks prior to each cyle of therapy.)
研究者
Francisco Robert,MD
Professor of Medicine
University of Alabama at Birmingham