A Phase I Study Of Tirapazamine (NSC 130181) Paclitaxel And Carboplatin With Concurrent Radiation Followed By Tirapazamine/Paclitaxel/Carboplatin Consolidation For Stage III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy 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. Tirapazamine may make the tumor cells more sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and tirapazamine may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with tirapazamine and radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of tirapazamine when administered with paclitaxel, carboplatin, and concurrent radiotherapy in patients with stage IIB-IIIB non-small cell lung cancer.
- Determine, preliminarily, the response rate and survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of tirapazamine.
Patients receive induction chemotherapy comprising tirapazamine IV over 2 hours and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and paclitaxel IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36, and 39. Beginning on day 1, patients undergo radiotherapy once daily 5 days a week for 6.5 weeks. Beginning 4-5 weeks after completion of radiotherapy, patients with stable or responding disease receive consolidation chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on days 1 and 22.
Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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 primary bronchogenic non-small cell lung cancer
- •Adenocarcinoma
- •Large cell carcinoma
- •Squamous cell carcinoma
- •Stage IIIA or IIIB disease (T1-4, N2-3)
- •Mediastinal lymph nodes at least 2 cm in diameter by radiography sufficient to stage N2-3 (must be node positive [cytologically or histologically confirmed] if largest mediastinal node is less than 2 cm in diameter) OR
- •Selected stage IIB disease (T3, N0 or T3, N1 with a medical condition that precludes surgery)
- •No malignant pleural effusion
- •Measurable or evaluable disease by chest x-ray or CT scan
- •No metastatic disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Zubrod 0-2 OR
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Platelet count normal
- •Not specified
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No uncontrolled congestive heart failure
- •No unstable angina
- •No unstable cardiac arrhythmias
- •FEV_1 at least 1.0 L
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No clinically significant hearing loss
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy for lung cancer
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy for lung cancer
- •See Disease Characteristics
排除标准
- 未提供