Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin-Etoposide/Carboplatin in Extensive SCLC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Objective Response Rate (Part I)
研究概览
简要总结
The primary objective of Part I of the study is to determine tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide /carboplatin in chemotherapy-naïve patients with extensive small cell lung cancer. The primary objective of Part II of the study is to determine the objective tumor response rate of irinotecan/oxaliplatin in patients with either refractory disease or who have relapsed to first line chemotherapy or chemoradiotherapy.
详细描述
This is a Phase II, open label study for either chemotherapy-naïve patients with extensive SCLC or patients who are refractory or have relapsed to 1st line therapy for SCLC. The primary objective is to determine the objective response rate.
This study consists of 2 parts:
Part I - Chemotherapy-naïve patients with extensive SCLC
• These patients will be treated with sequential topoisomerase targeting regimens (Regimen A and B). Regimen A consists of irinotecan and oxaliplatin (IROX), given on Day 1, and Neulasta administered on Day 2. Regimen B consists of etoposide and carboplatin, given on Day 15(etoposide will be given daily x 3)and Neulasta on Day 18. Then, Regimen A will be given again 3 weeks later. The first re-evaluation for response will be performed 3 weeks after the second round of the sequential regimens.
Schema of Part I:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of SCLC.
- •Measurable or assessable tumor parameters.
- •Eastern Cooperative Oncology Group (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
- •Platelet count ≥ 100,000/µL
- •SGOT/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.
- •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 (HIPAA).
- •Extensive-stage SCLC as defined as disease not confined to one hemithorax, including ipsilateral pleural effusion or pericardial effusion.
- •No prior chemotherapy.
- •For Part II
- •Patients with either refractory disease, or who have relapsed 1st line therapy. No prior chemotherapy with Oxaliplatin or irinotecan.
- •Demonstrated tumor progression at the time of study entry.
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.
结局指标
主要结局
Objective Response Rate (Part I)
时间窗: baseline to 18 months
The primary objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.
Response Rate After Relapse
时间窗: 3 weeks after 3rd cycle of starting therapy after relapse or refractory disease
The objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.
次要结局
- Progression Free Survival (Part I)(baseline to five years)
- Overall Survival (Part I)(baseline to 2 years)
研究者
Francisco Robert,MD
Professor of Medicine
University of Alabama at Birmingham