NCT01079481已完成1 期
A Phase I Study of Combination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated dose (MTD) of everolimus when combined with fixed dose of paclitaxel in small cell lung cancer patients
研究概览
简要总结
The objective of this phase I study is to determine the maximum tolerated dose (MTD) of combination therapy of paclitaxel and everolimus in small cell lung cancer patient with previous treatment history.
详细描述
Small cell lung cancer (SCLC) accounts for 15% to 20% of all lung cancer, and more than half of these patients are diagnosed with extensive-stage disease (ED). SCLC is a particularly aggressive form of lung cancer with a tendency for rapid tumor growth, early dissemination and high frequency of the metastasis In this study, we evaluate the MTD of everolimus combined with paclitaxel combination chemotherapy in SCLC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed small cell lung cancer
- •Regarding a limited disease, the disease in a patient, who had concurrent chemoradiation therapy before, is relapsed or progressing, the patient should have received the first line platinum-based anticancer therapy. The disease should be progressing/relapsed during or after the previous treatment.
- •Regarding an extensive disease, the progression/relapse of the disease during or after the first line platinum-based anticancer therapy should be confirmed.
- •Patient with asymptomatic or treated brain metastasis.
- •Patients without current concomitant chemotherapy
- •Patients without current concomitant radiotherapy
- •Patients who are not receiving chronic treatment with steroids or another immunosuppressive agent.
- •Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST).
- •Patients aged 18 years or older
- •ECOG performance status 0-2
- •Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; hemoglobin > 9g/dL; -; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min.
- •Patients who signed and dated the informed consent form prior to specific study procedures.
- •Patients who can comply with the scheduled follow-up and toxicity management procedure.'
排除标准
- •Patients with history of treatment with mTOR inhibitors
- •Pregnant with gastrointestinal problem impairing absorption of drugs
- •Patients who could not use appropriate method of contraception
- •Pregnant or feeding patients
- •Other medically ill patients
- •Severe heart/pulmonary disease
- •DM patients
- •Other malignancy except cured skin cancer or uterine cervix carcinoma in situ
- •High cholesterolemia greater than grade 3
- •Patients with symptomatic brain metastasis
- •Chronic hepatitis or liver cirrhosis (patients with HBsAg positive, IgM anti-HBc positive or HCV Ab positive)
- •Patients receiving immunosuppressant
研究组 & 干预措施
taxol plus everolimus
Experimental
干预措施: taxol plus everolimus (Drug)
结局指标
主要结局
To determine the maximum tolerated dose (MTD) of everolimus when combined with fixed dose of paclitaxel in small cell lung cancer patients
时间窗: 18 months
次要结局
- To evaluate the safety when paclitaxel plus everolimus are given to patients with small cell lung cancer(18 months)
- To evaluate the objective response rate by RECIST 1.1 criteria(18 months)
研究者
Keunchil Park
Principal investigator
Samsung Medical Center
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)Esophageal CancerNCT00915850Wakayama Medical University32
已完成
1 期
A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDSSarcoma, KaposiHIV InfectionsNCT00000987National Institute of Allergy and Infectious Diseases (NIAID)36
已完成
1 期
A Dose Escalation Study of the Combination of Lenalidomide (Revlimid®), Dexamethasone and Cyclophosphamide in Patients Refractory or Relapsing From Stable Disease With Multiple MyelomaMultiple MyelomaNCT00915408King's College Hospital NHS Trust32
终止
1 期
Imatinib in Combination With Dacarbazine and Capecitabine in Medullary Thyroid CarcinomaSolid TumorThyroid CancerNCT00354523M.D. Anderson Cancer Center21
已完成
1 期
Oral SAR245408 (XL147) and Oral MSC1936369B in Patients With Locally Advanced or Metastatic Solid TumorsSolid TumorsNCT01357330Sanofi18