LCI-LUN-ABR-001: A Pilot Study of Carboplatin With Nab-Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer of Squamous Histology
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Participants With a Response
研究概览
简要总结
ABRAXANE, based on results from prior studies, is a promising drug in squamous cell carcinoma of the lung. This study will help to explore the combination of ABRAXANE and carboplatin more thoroughly in the subgroup of patients who had the best response in prior studies as well as determine whether there are any biomarkers which can predict for response.
详细描述
This is a single arm phase II study for subjects receiving first line therapy for metastatic squamous cell lung cancer. Following informed consent and eligibility check, all subjects will receive therapy with carboplatin and ABRAXANE on an outpatient basis. A total of 50 subjects will be enrolled over an enrollment period of about 24 months. Interim analyses will be conducted after the enrollment of subject 15, subject 30, and subject 45. Tissue biomarkers will be analyzed at baseline; and blood biomarkers will be analyzed at baseline, pre-dose on cycles 3 and 5, and then within 30 days of last dose of study treatment.
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 confirmed stage IV non-small cell lung cancer with predominantly squamous histology
- •No prior systemic treatment for metastatic disease. Patients who have received prior adjuvant chemotherapy for early-stage lung cancer are eligible if at least 12 months have elapsed between the date of final chemotherapy administration and the date of consent
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with CT scan, MRI, or calipers by clinical exam
- •Biopsy accessible disease
- •Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the recurrence is outside the original radiation therapy port. Definitive radiation therapy must have been completed >4 weeks prior to the date the informed consent is signed
- •Age >18 years
- •ECOG performance status less than or equal to 1
- •If patient has brain metastasis, the disease must be stable (treated and/or asymptomatic) for at least 4 weeks prior to first dose of study treatment
- •Bilirubin < 1.5 mg/dL
- •Adequate liver function: AST and ALT <= 2.5x upper limit of normal, alkaline phosphatase <= 2.5x upper limit of normal, unless bone metastasis is present (< 5x upper limit of normal) in the absence of liver metastasis
- •Adequate bone marrow function: Platelets >100,000 cells/mm3, Hemoglobin > 9.0g/dL and ANC > 1,500 cells/mm3
- •Adequate renal function with creatinine <1.5 mg/dL is recommended
- •Females of childbearing potential and sexually active males must use an effective contraception method during treatment and for six months after completing treatment
- •Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential
- •Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE version 4.0)
- •Ability to understand and the willingness to sign a written informed consent document
- •Exclusion Criteria
- •Received prior systemic therapy for metastatic disease
- •Received limited field radiation for palliation <= 2 weeks prior to starting study treatment and/or from whom >= 30% bone marrow was irradiated
- •Receiving any other investigational agents
- •Known hypersensitivity to either carboplatin or ABRAXANE
- •Uncontrolled and current 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
- •Pregnant or breast feeding
- •Other active malignancies
- •Neuropathy greater than or equal to grade 2
排除标准
- 未提供
研究组 & 干预措施
Carboplatin + Abraxane
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
干预措施: Carboplatin (Drug)
Carboplatin + Abraxane
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
干预措施: Abraxane (Drug)
结局指标
主要结局
Number of Participants With a Response
时间窗: Up to a planned 18 weeks
The primary endpoint is a binary variable determined for each patient indicating whether or not they achieved a complete response (CR) or a partial response (PR) as per RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions and a PR is indicated by \>= 30% decrease in sum of longest diameter of target lesions with baseline as reference). Because overall response is the primary endpoint for this study, best responses of CR or PR must be confirmed by a subsequent radiologic assessment.
次要结局
- Overall Survival(From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years)
- Duration of Response(From date of response to date of progression/death, or censored as described above; assessed for approximately 3 years.)
- Duration of Disease Control(From date of treatment start to date of progression, or censored as described above; assessed for approximately 3 years)
- Number of Subjects With Stable Disease or Response(18 weeks)
- Progression Free Survival(From date of treatment start to date of progression/death, or censored as described above; assessed for approximately 3 years)