A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy in a multi-institutional trial. Consolidation chemotherapy with paclitaxel poliglumex and carboplatin will follow the completion of chemoradiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas).
- •Eligible Disease Stages: Inoperable IIIA and Selected IIIB
- •Local radiation oncologist must approve patient eligibility prior to entry on study.
- •Patients must have measurable disease.
- •Prior Therapy:
- •≥ 2 weeks since formal exploratory thoracotomy.
- •No prior chemotherapy or radiation therapy for NSCLC.
- •ECOG performance status 0-1
- •Required Initial Laboratory Values (must be submitted within 16 days prior to registration):
- •Granulocytes ≥ 1,500/µl
- •Platelets ≥ 100,000/µl
- •Calculated Creatinine Clearance ≥ 20 cc/min
- •Bilirubin < 1.5 mg/dl
- •AST (SGOT) < 2 x ULN
- •INR > 0.8 < 1.2* *Values apply exclusively to patients not being treated with warfarin. Values for patients being treating with warfarin should fall within the following therapeutic range: > 2.0 < 3.0.
排除标准
- •Currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
- •Pregnant or nursing because of significant risk to the fetus/infant.
- •Age <18 years.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •No HIV-positive patients receiving combination anti-retroviral therapy. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy
- •One-second forced expiratory volume (FEV1) <50% or hemoglobin-corrected carbon monoxide diffusion capacity (DLCO) <50% of predicted, as measured within 21 days of study entry
- •Symptoms of esophageal dysfunction (dysphagia, odynophagia, or inability to swallow solid food) within 4 weeks prior to study randomization. Patients must not require prophylactic placement of percutaneous enterogastrostomy (PEG) tube or other non-oral nutritional supplement methods
- •Weight loss of > 10% in the past 3 months.
研究组 & 干预措施
Cohort 1 (first 12 eligible patients)
Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
干预措施: Paclitaxel poliglumex (Drug)
Cohort 1 (first 12 eligible patients)
Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
干预措施: Carboplatin (Drug)
Cohort 1 (first 12 eligible patients)
Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
干预措施: External beam radiation therapy (Radiation)
Cohort 2 (remaining patients)
Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
干预措施: Paclitaxel poliglumex (Drug)
Cohort 2 (remaining patients)
Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
干预措施: Carboplatin (Drug)
Cohort 2 (remaining patients)
Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
干预措施: External beam radiation therapy (Radiation)
结局指标
主要结局
Overall Survival (OS)
时间窗: Completion of follow-up (follow-up ranged from 3 months to 6 years)
OS = time from patient registration to death of all causes
Overall Survival (OS) Rate
时间窗: 6 months
* OS = time from patient registration to death of all causes * Estimated using Kaplan Meier
次要结局
- Response Rates(4 years)
- Incidence and Severity of Radiation-induced Esophagitis(30 days following completion of treatment (approximately 114 days))
- Failure-free Survival (FFS) Rate(6 months)
- Failure-free Survival (FFS)(Completion of follow-up (follow-up ranged from 3 months to 6 years))
- Incidence and Severity of Radiation-induced Pneumonitis(30 days following completion of treatment (approximately 114 days))