Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 157
- 主要终点
- Objective Response Rate (Proportion of Patients With Objective Response)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with recurrent or stage IIIB or stage IV lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in patients with recurrent or stage IIIB or IV bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features treated with cetuximab.
Secondary
- Determine the overall survival and time to progression in patients treated with this drug.
- Determine the toxic effects of this drug in these patients.
- Correlate expression of total and phosphorylated epidermal growth factor receptor (EGFR), total and phosphorylated AKT3, and total and phosphorylated MAPKinase with response in patients treated with this drug.
- Determine whether the presence of polymorphisms or mutations in the EGFR gene influences response in patients treated with this drug.
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 bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features meeting 1 of the following stage criteria:
- •Stage IIIB disease (with pleural or pericardial effusion)
- •Stage IV disease
- •Recurrent disease
- •Measurable disease
- •Tumor tissue available from biopsy
- •Age of 18 and over
- •ECOG performance status of 0-2
- •Life expectancy greater than 3 months
- •White blood cell (WBC) ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin normal
- •Aspartate aminotransferase (AST) and/or alanine aminotranferease (ALT) ≤ 2.5 times upper limit of normal
- •Creatinine normal OR Creatinine clearance ≥ 60 mL/min
- •No more than 1 prior chemotherapy regimen for advanced BAC
- •More than 3 years since prior chemotherapy for other malignancies
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for this malignancy and recovered
- •HIV-positive patients are eligible provided the following criteria are met:
- •CD4 count ≥ 100/mm^3
- •Undetectable viral load within the past 3 months
- •Receiving a stable antiretroviral regimen for ≥ 4 weeks before study entry
- •Fertile patients must use effective contraception
- •At least 2 weeks since prior radiotherapy and recovered
排除标准
- •Untreated brain metastases
- •Patients with stable brain metastases ≥ 4 weeks after external beam radiotherapy to the brain are eligible
- •Acute hepatitis
- •Symptomatic congestive heart failure
- •Uncontrolled hypertension
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Pregnant or nursing
- •Prior allergic reaction to chimerized or murine monoclonal antibody therapy
- •Documented presence of human anti-mouse antibodies
- •Ongoing or active infection
- •Psychiatric illness or social situation that would preclude study compliance
- •Other uncontrolled illness
- •Prior cetuximab
- •Concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- •Other prior known epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib)
- •Other concurrent investigational agents
- •Other concurrent anticancer therapy
研究组 & 干预措施
Cetuximab
Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.
干预措施: cetuximab (Biological)
结局指标
主要结局
Objective Response Rate (Proportion of Patients With Objective Response)
时间窗: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years
Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.
次要结局
- Overall Survival(Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years)
- Time to Progression(Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years)
- Overall Survival by Smoking Status(Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline)
- Time to Progression by Smoking Status(Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline)