A Phase II Trial of Carboplatin and Irinotecan (CPT-11) as First-Line Therapy for Patients With Extensive Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Patient Response
研究概览
简要总结
RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have been very encouraging. As the toxicity profile associated with carboplatin is preferable over cisplatin it is our expectation that patients and physicians would prefer to use this combination if it is equally or more efficacious. To date there has been no agreement regarding the optimal combination of these agents. Based on the trials described in the protocol and our experience with carboplatin/irinotecan in the treatment of non-small cell lung cancer the present trial will utilize a 21-day cycle of irinotecan 50 mg/m2 given on days 1 and 8 and carboplatin AUC 5 (based on the Calvert formula) on day 1.
PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works as first-line therapy in treating patients with extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To examine the anti-tumor efficacy of the combination of Irinotecan (CPT-11) and Carboplatin as first-line therapy as assessed by response rate in patients with chemo-naïve extensive stage small cell lung cancer.
Secondary
- Determine the safety, tolerability, and feasibility of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
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
- •Histologically or cytologically confirmed small cell lung cancer (SCLC)
- •Extensive stage small cell lung cancer
- •Must have ≥ 1 unidimensionally measurable lesion (longest diameter to be recorded) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- •Lesion cannot be from a previously irradiated area
- •Lesions that are considered nonmeasurable include the following:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •Tumor lesions in a previously irradiated area
- •No brain metastasis or carcinomatous meningitis unless stable and asymptomatic
- •PATIENT CHARACTERISTICS
- •ECOG performance status 0-2
- •Life expectancy ≥ 3 months
- •ANC ≥ 1,500/mm³
- •Platelet count > 100,000/mm³
- •Serum bilirubin ≤ 1.5 mg/dL
- •AST/SGOT ≤ 2.5 times upper limit of normal (ULN) (or ≤ 5 times ULN if liver metastases present)
- •Serum creatinine ≤ 2.0 mg/dl
- •Hemoglobin ≥ 9.0 g/dl
排除标准
- •CNS metastasis excluded unless: stable and asymptomatic
- •Coexisting medical condition that would preclude study compliance
- •Patients with Gilbert's disease
- •Uncontrolled diabetes mellitus, defined as random blood sugar ≥ 300 mg/dl or > 16.6 mmol/L
- •Patients who do not discontinue phenytoin, phenobarbitol, carbamazipine, or other enzyme-inducing anticonvulsant drugs at least 7 days prior to first treatment dose on study. Gabapentin is permitted
- •Patients who do not discontinue St. John's Wort prior to first treatment dose on study.
- •Patients who are pregnant or breast feeding
- •Concomitant second active malignancy except for any in situ cancer or adequately treated basal cell or squamous cell skin cancer or any cancer from which the patients has been disease-free for at least 2 years
- •No administration of any prior systemic anticancer therapy for extensive stage SCLC such as: chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents. Concurrent use of other anticancer therapy including inhibitors of vascular endothelial or epidermal growth factor pathways is prohibited. Prior radiation is allowed
- •Symptomatic brain metastasis or carcinomatous meningitis
- •PRIOR CONCURRENT THERAPY:
研究组 & 干预措施
Therapeutic Intervention
Lung cancer patients will be treated for four 3-week cycles (12 weeks) in the absence of progressive disease, unacceptable toxicity, or withdrawal of patient consent. Up to two additional cycles may be administered at the discretion of the treating physician. If at treatment withdrawal the disease has responded or is stable, the patient will continue to be followed for efficacy (i.e. until progressive disease)at 8 week intervals. Following the diagnosis of progressive disease, patients will be followed every two months for survival.
干预措施: Carboplatin (Drug)
Therapeutic Intervention
Lung cancer patients will be treated for four 3-week cycles (12 weeks) in the absence of progressive disease, unacceptable toxicity, or withdrawal of patient consent. Up to two additional cycles may be administered at the discretion of the treating physician. If at treatment withdrawal the disease has responded or is stable, the patient will continue to be followed for efficacy (i.e. until progressive disease)at 8 week intervals. Following the diagnosis of progressive disease, patients will be followed every two months for survival.
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Patient Response
时间窗: 1.66 months (average duration, on treatment date to best response date)
Patient response to treatment: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
次要结局
- Number of Patients With Adverse Events(date off treatment or progression of disease, up to 18 weeks)
- Time to Progression(9.9 months (on study date to progression))
- Overall Survival(On study date to death)
研究者
Leora Horn, MD
Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center