A Phase II Study of Gemcitabine Plus Oxaliplatin for Patients With Advanced Stage IIIB or IV Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Oxaliplatin is a diaminocyclohexane platinum compound, with a mechanism of action similar to that of cisplatin. Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities. Gemcitabine and oxaliplatin are both active in NSCLC with no overlapping toxicity. Preclinical studies show a synergistic effect of the gemcitabine-oxaliplatin combination. The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index.
详细描述
The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index. We are conducting a phase II study to evaluate the response rate and toxicity of the gemcitabine-oxaliplatin combination both given every 4 weeks in patients with advanced NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologic or cytologic diagnosis of NSCLC, Stage IV or selected stage IIIB (with positive pleural effusion or separate tumor nodules in the same lobe) according to the American Joint Committee on Cancer (AJCC).
- •No prior chemotherapy.
- •Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
- •No other forms of cancer therapy, such as radiation, immunotherapy for at least 4 weeks before the enrollment in study.
- •Performance status of 0, 1, 2 on the ECOG criteria.
- •At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
- •Estimated life expectancy of at least 12 weeks.
- •Patient compliance that allow adequate follow-up.
- •Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 3,500/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, and platelet count ≥ 100,000/uLAdequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.
- •Informed consent from patient
- •Males or females at least 18 years old.
- •If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study registration.
排除标准
- •MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
- •Serious concomitant infection including post obstructive pneumonia
- •Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- •Pregnant or nursing women
- •Psychiatric disorder that would preclude compliance.
- •Major surgery other than biopsy within the past two weeks.
研究组 & 干预措施
study arm
GemOx
干预措施: Oxaliplatin (Drug)
study arm
GemOx
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Response rate
时间窗: every 12 weeks during until disease progression
次要结局
- To evaluate the improvement quality of life(before the first treatment and every cycle d1 until diseas progression)
- To estimate the time to progression and overall survival(the first day of treatment to the date that disease progression is reported)
- To access the toxicity(the first day of the treatment to 30 days after the last dose of study drug)
- To estimate the overall survival(the first day of the treatment to death date)