Phase I/IIa Study of the Novel Combination of Bendamustine With Irinotecan Followed by Etoposide/Carboplatin in Chemonaive Patients With Extensive Stage Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Patients With Adverse Events - Phase II
研究概览
简要总结
Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two thirds of new cases and is generally considered sensitive to chemotherapy, despite a median time to progression of 4 months. SCLC is one of the most aggressive and lethal types of cancer, with a median survival of 9 months (range 7-11 months) in patients diagnosed with extensive disease. Overall, the majority of patients with SCLC die in less than 2 years (2-year survival rates generally less than 10%), and the 5-year survival rate is 2.3% for patients with extensive disease. The regimen of etoposide in combination with a platinum (cisplatin or carboplatin) is generally considered the "standard of care" although a recent Phase III trial suggests improved survival with the combination of cisplatin/irinotecan. Further evaluation of new agents in combination regimens attempting to overcome the intrinsic drug resistance seen in extensive-stage SCLC is warranted attempting to improve survival and achieve palliation of disease-related symptoms.
详细描述
We are proposing a novel combination of bendamustine plus irinotecan followed by the standard regimen of etoposide with carboplatin. This will allow the investigation of response to the novel combination as well as any improvement in outcomes compared to historical controls.
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 extensive stage SCLC.
- •Measurable or assessable tumor parameters.
- •ECOG Performance Status 0-
- •Age between 18 and 79 years (in the State of Alabama > 18).
- •Adequate bone marrow, liver and renal function, defined as:
- •Absolute neutrophil count (ANC) ≥ 1500/µL
- •Hemoglobin ≥ 8g/dl
- •Platelet count ≥ 100,000/µL
- •SGOT/SGPT ≤ 2 x upper limit of normal or ≤ 5 x upper limit of normal when liver metastases are present.
- •Total bilirubin value ≤ 2 x upper limit of normal.
- •Serum creatinine value ≤ 2 x upper limit of normal.
- •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 subjects 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 (HIPAA).
- •Extensive-stage SCLC as defined as disease not confined to one hemithorax, including ipsilateral pleural effusion or pericardial effusion.
- •No prior chemotherapy.
排除标准
- •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.
- •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.
- •Neuropathy at baseline ≥ Grade
- •Any evidence or history of hypersensitivity or other contraindications for the drugs used in this trial.
- •History of chronic diarrhea; or diarrhea (excess of 2-3 stools/day above normal frequency) in the past 2 weeks.
- •History of a positive serology for human immunodeficiency virus (HIV).
- •Psychiatric disorder that prevents patients from providing informed consent or following protocol instructions.
- •Pregnant or lactating women.
研究组 & 干预措施
Novel Drug Combination
This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin.
This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.
干预措施: Novel Drug Combination (Drug)
结局指标
主要结局
Number of Patients With Adverse Events - Phase II
时间窗: 9 weeks
The degree of toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3.
Number of Participants Experiencing Dose Limiting Toxicity Regimen A - Phase I
时间窗: 9 weeks
The determination of the dose limiting toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3 as follows: grade 4 neutropenia \>5 days; grade 3/4 febrile neutropenia; grade 4 thrombocytopenia; or grade \>2 non-hematologic toxicities (except for nausea/vomiting, alopecia, or fatigue).
次要结局
- Progression Free Survival(7 months)
研究者
Francisco Robert,MD
Professor
University of Alabama at Birmingham