NCT01038752终止2 期
Combination of Non-Cytotoxic Suramin With Docetaxel and Carboplatin in Chemo-Naive Non-small Cell Lung Cancer (NSCLC): A Randomized Single-Blind Placebo-Controlled Phase II Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria
研究概览
简要总结
The purpose of this study is to evaluate the benefit of adding suramin at a non-cytotoxic dose to carboplatin and docetaxel regimen in the treatment of chemo-naïve patients with non-small cell lung cancer.
详细描述
The primary objective is to determine the progression free survival for patients with stage III B with malignant pleural effusion or Stage IV NSCLC treated with docetaxel and carboplatin with or without suramin.
The secondary objectives are to compare median overall survival rate, compare overall response rate of patients in both arms, assess toxicity of suramin with docetaxel and carboplatin, determine whether pre-treatment bFGF levels correlate with survival, to determine whether survival benefit from suramin is associated with M phase entry in peripheral blood lymphocytes, and to determine whether adding suramin to docetaxel and carboplatin produces greater survival benefits in African-American patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 proven on-small cell lung cancer (NSCLC), including squamous cell carcinoma.
- •Newly-diagnosed stage IIIB with malignant pleural effusion, stage IV or recurrent disease.
- •Known central nervous system metastases if patients are asymptomatic and have completed whole brain or stereotactic radiation at least 2 weeks prior or surgery at least 4 weeks prior to starting treatment on this protocol. Must be off dexamethasone at the time of starting treatment.
- •Must have completed radiotherapy at least two weeks prior to registration. Prior radiation therapy is eligible if patient has a measurable lesion that has not been irradiated.
- •Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (RECIST criteria).
- •Lesions that are not considered measurable include the following:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Cystic lesions
- •Tumor lesions situated in a previously irradiated area
- •ECOG performance status of 0-
- •Life expectancy ≥ 3 months.
- •Adequate bone marrow function, absolute neutrophil count ≥1,500/mm3, hemoglobin ≥9.9 gm/dl, and platelet count ≥100,000/mm
- •Adequate liver function defined as bilirubin ≤ 1x upper level of the institutional normal (ULIN). AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. See protocol.
- •Must have adequate renal function defined as serum creatinine ≤ 2.0 mg/dl or calculated creatinine clearance ≥ 60 ml/min for patients with creatinine levels above 2.0 mg/dl.
- •Must have recovered from uncontrolled intercurrent illness, including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
- •Use of adequate contraception (hormonal or barrier method of birth control) for the duration of study participation and continued for at least three months after completing treatment. Non-pregnant status will be determined in all women of childbearing potential.
- •Patients must have given written informed consent.
- •Entry to this study is open to both men and women and to all racial and ethnic subgroups. The goal is to accrue a minimum of 44 patients of African-American ancestry and a maximum of 120 non-African-American patients. Classification of patient race and ancestry will be based on patient's self-identification on the consent form for the clinical trial.
排除标准
- •History of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate
- •Grade 3 or 4 neuropathy.
- •Women who are pregnant or breast-feeding.
- •Prior chemotherapy or biologic therapy (e.g., erlotinib) for NSCLC including neoadjuvant or adjuvant chemotherapy.
- •Currently active second malignancy other than non-melanoma skin cancer. Currently active malignancy does not include prior malignancy treated with therapy and considered to have less than 30% risk of relapse.
结局指标
主要结局
Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria
时间窗: Patients will be followed every 2 months for the first 6 months following the last cycle of treatment, every three months for the next year, and every 6 months thereafter.
Insufficient data
次要结局
- Overall Survival of Participants(First treatment date to date of death)
- Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes(Randomization date)
- Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.(Day 1 of each cycle; end of treatment visit; at follow-up.)
- Overall Response Rate (Complete Response + Partial Response) of Participants(Tumor assessment at every other cycle)
- Pre-treatment bFGF Levels Correlation With Survival.(Before first treatment)
- To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients.(Randomization date to date of death)
- To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Greater Survival Benefits in African-American Patients Compared to Non-African-American Patients.(Randomization date to date of death)
研究者
研究点 (4)
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