Phase 2 Study Evaluating the Safety and Efficacy of Eloxatin (Oxaliplatin) and Docetaxel as First-line Therapy of Stage IV or IIIB Unresectable Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination.
详细描述
This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination. The primary objective of the study is response rate by RECIST criteria. The secondary objective is time to progression, duration of response, and toxicity. Patients will receive:
- oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15
- docetaxel 30mg/m2 on Days 1 and 8
Cycles are to be repeated every 28 days for a maximum of 6 cycles.
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 non-small-cell lung cancer (NSCLC)
- •Patients must have measurable disease
- •Age greater than or equal to 18 years
- •ECOG performance score of 0, 1, or 2
- •Absolute neutrophil count (ANC) > 1,500
- •Platelets > 100,000
- •Serum creatinine < 1.5mg/dL
- •Serum total bilirubin < 1.5mg/dL
- •Alkaline phosphatase < 3 times the upper limit of normal
- •SGOT/SGPT < 3 times the upper limit of normal
- •Patients must be recovered from the effects of any prior surgery or RT.
- •Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
- •Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medications.
排除标准
- •Patients with an active infection > 38.5 degrees Celsius within 3 days of the first scheduled day of protocol treatment
- •Patients with active central nervous system (CNS) metastasis. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 2 weeks are eligible for the trial.
- •History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasm, or localized prostate cancer with a current prostate specific antigen (PSA) of < 1.0 mg/dL
- •Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel
- •Patients who have had prior chemotherapy for lung cancer
- •Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
- •Grade 2 peripheral neuropathy
- •Patients who are pregnant or lactating
- •Any other medical condition, including mental illness or substance abuse deemed by the investigator to be likely to interfere with the patients' ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
- •History of allogeneic transplant
- •Known HIV, hepatitis B or C (active, previously treated, or both)
研究组 & 干预措施
1
Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. The primary objective of the trial is to determine the response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC.
干预措施: Oxaliplatin + Docetaxel (Drug)
结局指标
主要结局
Response Rate
时间窗: Response is measured every 2 cycles until disease progression
Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.
次要结局
- Time to Progression(<1 cycle to 6 cycles of treatment)
- Duration of Response(0 -12 months)
- Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.(day one of cycle one until participant removed from trial)
研究者
Dr. Sigrun Hallmeyer
Principal Investigator
Oncology Specialists, S.C.