NCT00062322已完成1 期
Phase I Study of Preoperative Chemo/Radiation (Concurrent Irinotecan/Cisplatin/RT) Followed by Surgery in Limited Stage Small Cell Lung Cancer (SCLC-LS)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Irinotecan and cisplatin may also make the tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: This phase I trial is studying the side effects of neoadjuvant radiation therapy given together with irinotecan and cisplatin followed by surgery in treating patients with limited-stage small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the safety and feasibility of neoadjuvant chemoradiotherapy with irinotecan and cisplatin followed by surgery in patients with limited stage small cell lung cancer.
- Determine the pathologic complete response rate of patients treated with this regimen.
- Correlate the level of vascular endothelial growth factor with treatment response and disease outcome in patients treated with this regimen.
- Correlate genetic polymorphisms in cytochrome P450 1A1, glutathione S-transferase M1 and P1, myeloperoxidase, and NAD(p)H: quinone oxidoreductase with treatment response and disease outcome in patients treated with this regimen.
OUTLINE: This is a pilot study.
- Induction chemotherapy: Patients receive cisplatin IV over 1 hour on day 1 and irinotecan IV over 90 minutes on days 1 and 8.
- Chemoradiotherapy: Beginning on day 21, patients receive chemoradiotherapy comprising radiotherapy once daily, 5 days a week for 4 weeks and then twice daily for 4 days. Patients also receive cisplatin IV and irinotecan IV over 30-60 minutes once weekly concurrently with radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
At the completion of chemoradiotherapy, patients are evaluated for surgery. Patients who are candidates for surgery receive one additional course of cisplatin IV and irinotecan IV. Patients who are not candidates for surgery receive radiotherapy twice daily for 4 days and cisplatin IV and irinotecan IV as in chemoradiotherapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed small cell lung cancer
- •Limited stage disease (clinical stage I-IIIA) and meets the following criteria:
- •Confined to 1 hemithorax
- •No T4 disease based on malignant pleural effusion
- •No N3 disease based on contralateral hilar or supraclavicular involvement
- •Contralateral mediastinal (N3) nodes greater than 1.5 cm on CT scan must be biopsied to rule out pathologic involvement
- •Measurable or evaluable disease
- •Tumor must be able to be encompassed by limited radiotherapy field without significantly compromising pulmonary function
- •No pleural effusion visible on chest x-ray (regardless of cytology)
- •No prior complete tumor resection
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count at least 1,800/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •No known Gilbert's disease
- •Creatinine no greater than 1.5 mg/dL
- •Calcium less than 12.0 mg/dL
- •Cardiovascular
- •No myocardial infarction within the past 6 months
- •No congestive heart failure
- •No uncontrolled arrhythmias
- •No active unstable angina
- •Calculated postoperative FEV_1 at least 800 cc
- •No chronic obstructive pulmonary disease with FEV_1 no greater than 1 L or uncontrolled bronchospasm in the unaffected lung
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other noninvasive malignancy
- •No history of seizures
- •No history of uncontrolled psychiatric illness that would preclude giving informed consent or complying with study
- •No active or uncontrolled infection
- •No uncontrolled diabetes mellitus (random blood sugar at least 250 mg/dL)
- •No other concurrent serious medical illness
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior irinotecan
- •No prior topotecan
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Irinotecan in Treating Patients With Metastatic Colorectal CancerColorectal CancerNCT00003544Memorial Sloan Kettering Cancer Center
已完成
2 期
Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile CancerPenile CancerNCT00066391European Organisation for Research and Treatment of Cancer - EORTC
已完成
1 期
Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung CancerLung CancerNCT00059761Radiation Therapy Oncology Group36
已完成
1 期
Carboplatin and Irinotecan in Treating Children With Refractory Solid TumorsUnspecified Childhood Solid Tumor, Protocol SpecificNCT00024284Bristol-Myers Squibb
已完成
1 期
Irinotecan, Radiation Therapy, and Docetaxel With or Without Cisplatin in Treating Patients With Locally Advanced Esophageal CancerEsophageal CancerNCT00601692Memorial Sloan Kettering Cancer Center27