NCT00492206已完成2 期
A Phase II Study of Cetuximab in Combination With External Beam Radiation Followed By Consolidation Chemotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
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
- 40
- 试验地点
- 31
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC.
详细描述
This is a Phase II study to determine the overall survival for patients with locally advanced NSCLC treated with cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab. This is a multicenter study including 36 subjects who will be males and females, both greater than 18 years of age. All subjects will initially receive radiation and cetuximab. Radiation will be given once a day (Monday-Friday) for approximately 6-8 weeks. During the course of radiation, cetuximab will be given intravenously once a week. Approximately 4-6 weeks after the last radiation dose, the subjects will be treated with chemotherapy, paclitaxel/carboplatin. Chemotherapy will be given intravenously once every 3 weeks for 3 cycles (1 cycle=3 weeks). Cetuximab intravenous administration will be continued throughout the entire study, once a week through week 26 including during chemotherapy.
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
- •Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer
- •Patients must have surgically unresectable stage IIIA disease or stage IIIB disease without malignant pleural/pericardial effusion
- •Patients must have measurable disease as per the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease.
- •Age >18 years. Lung cancer is extremely rare in children.
- •ECOG performance status 0-1 (Karnofsky >70%; see Appendix A).
- •If available, tumor tissue should be submitted for EGFR status by IHC and correlative studies.
- •Patients must have normal organ and marrow function as defined below:
- •leukocytes >3,000/μL
- •absolute neutrophil count >1,500/μL
- •platelets >100,000/μL
- •total bilirubin within normal institutional limits
- •AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- •creatinine within normal institutional limits OR
- •creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- •The effects of cetuximab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because EGFR inhibitors, chemotherapeutic agents and radiation therapy, as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Patients must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- •Willingness to sign an approved informed consent.
排除标准
- •Patients should not have received prior chest radiation therapy.
- •Patients with a history of pulmonary fibrosis are excluded from study.
- •Patients may not be receiving any other investigational agents.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, cetuximab or other agents used in the study.
- •History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.
- •Prior therapy with known specific inhibitors of the EGFR.
- •History of severe allergic reaction to prior therapy with monoclonal antibodies
- •Peripheral neuropathy of more than grade 1 in severity
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, significant history of uncontrolled cardiac disease ie. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure,and cardiomyopathy with decreased ejection fraction, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study because carboplatin, paclitaxel, cetuximab and radiation therapy have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the above agents, breastfeeding should be discontinued if the mother is treated with the agents used in this study. These potential risks may also apply to other agents used in this study.
- •Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin, paclitaxel and cetuximab or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
- •Active hepatitis.
- •History of pulmonary fibrosis.
研究组 & 干预措施
Cetuximab
Experimental
Cetuximab 400 mg/m2 IV week 0 only
External beam radiation weeks 1 - 7
Cetuximab 250 mg/m2 IV weekly thereafter weeks 1 - 7
Cetuximab 250 mg/m2 IV weekly weeks 8 - 26
Carboplatin AUC = 6 IV Paclitaxel 200 mg/m2 IV Every 3 weeks x 3 Cycles
干预措施: Cetuximab (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 36 months
次要结局
- Progression-free Survival (PFS)(Up to 36 months)
- Best Overall Response Rate (ORR) (Number of Participants)(Up to 12 weeks after treatment initiation)
- EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase(approx. 5 years)
研究者
Ahmad Tarhini
Associate Professor of Medicine and Translational Science
University of Pittsburgh
研究点 (31)
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