NCT01042288已完成2 期
A Phase II Trial of Carboplatin, Pemetrexed, and Panitumumab in Patients With Advanced Non-Squamous K-ras Wild Type Non-Small-Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 13
- 主要终点
- Median Time to Progression (TTP)
研究概览
简要总结
The purpose of this multicenter, Phase II trial is to examine the role of a well-tolerated novel agent, panitumumab, in combination with a modern platinum doublet regimen using carboplatin and pemetrexed, in patients with advanced non-squamous wild type K-ras non-small-cell lung cancer (NSCLC). If this treatment proves to be well tolerated and associated with efficacy, this would provide rationale for further randomized studies.
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
- •Age ≥18 years.
- •Histologically confirmed non-squamous NSCLC (squamous cell histology is ineligible). Cytologic specimens obtained by brushings, washings or needle aspiration of the defined lesion are acceptable. Sputum cytology alone is not acceptable. Mixed tumors with small cell elements are not eligible.
- •Newly diagnosed unresectable stage IIIB or stage IV disease. Patients with stage IIIB disease should be ineligible for combined modality therapy (i.e., pleural effusions, pericardial effusions, etc.).
- •At least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan. Measurable disease is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Demonstration of K-ras wild type in archived tumor tissue. Tissue must be available for testing or results from previous K-ras testing must be available at the time of registration.
- •No prior antineoplastic chemotherapy for metastatic lung cancer. Patients may have received adjuvant treatment for stage I, II or III disease.
- •For patients who have had previous radiotherapy as definitive therapy for locally advanced NSCLC, recurrence must be outside of the original radiation therapy port. Radiation therapy must have been completed more than four weeks prior to study entry. Previous radiation must have covered < 30% of marrow bearing area.
- •Full recovery from surgery for patients who have undergone thoracotomy. Patients cannot start protocol treatment until at least three weeks after an operative procedure.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy ≥ 12 weeks.
- •Normal bone marrow function within 7 days prior to initial treatment as defined by:
- •absolute neutrophil count (ANC) ≥1500/µL
- •platelets ≥100,000/µL
- •hemoglobin ≥8.0 g/dL. Patients may receive transfusions or erythropoietin to maintain or exceed this level.
- •Normal hepatic function as defined by:
- •bilirubin ≤1.5 x institutional upper limit of normal (ULN).
- •transaminases ≤2.5 x institutional ULN. In the presence of known hepatic metastases, transaminases may be ≤5 x institutional ULN.
- •Normal renal function within 7 days prior to initial treatment as defined by:
- •serum creatinine <2.0 mg/dL
- •estimated creatinine clearance (CrCl) ≥ 45 mL/min calculated by the Cockcroft-Gault method.
- •Normal metabolic function as follows:
- •Magnesium ≥ institutional lower limit of normal (LLN)
- •The ability to take folic acid, vitamin B12, and dexamethasone according to the protocol.
- •The ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
- •Negative serum or urine pregnancy test within 7 days prior to initial study treatment.
- •Agreement of women of child-bearing potential (WOCBP) and men to use adequate contraception (hormonal or barrier method of birth control; abstinence) to prevent contraception during treatment and for a minimum of 6 months after the last study treatment.
- •Willingness and ability to comply with study and follow-up procedures.
- •Ability to understand the nature of this study and give written informed consent.
排除标准
- •NSCLC with squamous cell histology.
- •History of any invasive cancer treated within the previous 5 years with the exception of the disease under study, curatively treated non melanoma skin cancer or carcinoma in situ of the cervix.
- •Prior therapy which specifically and directly targets the EGFR pathway (e.g., cetuximab, gefitinib, erlotinib, lapatinib).
- •Active brain or meningeal metastases. Patients must have completed any previous radiotherapy at least four weeks prior to study entry and recovered from any toxicity associated with radiotherapy. Patients must have no on-going requirement for and must have discontinued corticosteroids.
- •Pregnancy or breast-feeding.
- •A serious active infection at the time of treatment or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
- •Acute hepatitis or known human immunodeficiency virus (HIV) infection.
- •Presence of third space fluid which is clinically significant and cannot be controlled by drainage.
- •History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan).
- •History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.
- •Prior severe infusion reaction to a monoclonal antibody or history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study (e.g., carboplatin, pemetrexed).
研究组 & 干预措施
Carboplatin/Pemetrexed/Panitumumab
Experimental
Systemic Therapy
干预措施: Carboplatin (Drug)
Carboplatin/Pemetrexed/Panitumumab
Experimental
Systemic Therapy
干预措施: Pemetrexed (Drug)
Carboplatin/Pemetrexed/Panitumumab
Experimental
Systemic Therapy
干预措施: Panitumumab (Drug)
结局指标
主要结局
Median Time to Progression (TTP)
时间窗: 18 months
Defined as the time between Day 1-Cycle 1 and date of first documented disease progression assessed using Response Evaluation Criteria in Solid Tumors (RECISTS) v1.1.
次要结局
- Median Progression-free Survival (PFS)(Assessments by clinical evaluation, radiographic status, and date of disease progression, estimated 18 months)
- Median Overall Survival (OS)(18 months)
- Objective Response Rate(Projected 18 months)
- Frequency of Adverse Events and Severity as a Measure of Toxicity(Every 3 weeks (1 cycle) for 6 cycles, then every 7 weeks thereafter)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
2 期
Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung CancerNon Small Cell Lung CancerNCT00906282SCRI Development Innovations, LLC46
Unknown
不适用
Pemetrexed/Carboplatin vs Vinorelbine/Carboplatin in Patients With Completely Resected Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung CancerNCT01258127Shanghai Nancy Medical Sci-Tech Co. Ltd134
已完成
1 期
A Study of Carboplatin and Pemetrexed Plus Demcizumab (OMP-21M18) in Subjects With Non-Squamous Non-Small Cell Lung CancerNon Small Cell Lung CancerNCT01189968OncoMed Pharmaceuticals, Inc.50
终止
2 期
Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)Small Cell Lung CancerNCT00494026Eli Lilly and Company4
终止
2 期
Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLCNon-Small Cell Lung CancerNCT00960297SCRI Development Innovations, LLC4