Pemetrexed Plus Gemcitabine Or Carboplatin In Patients With Advanced Malignant Mesothelioma: A Randomized Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 115
- 主要终点
- Best Overall Response by RECIST Criteria (Version 1.0)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma.
PURPOSE: This randomized phase II trial is studying pemetrexed disodium with gemcitabine and pemetrexed disodium with carboplatin to see how well the combinations work compared to historical controls in treating patients with advanced malignant pleural mesothelioma.
详细描述
OBJECTIVES:
Primary
- Estimate the response rates in patients with advanced malignant mesothelioma of the pleura treated with pemetrexed disodium combined with either gemcitabine or carboplatin.
Secondary
- Assess the toxic effects of these regimens in these patients.
- Estimate survival time in patients treated with these regimens.
- Correlate smoking status with outcome in patients treated with these regimens.
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
- 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 advanced mesothelioma of the pleura
- •Measurable disease, as defined by RECIST criteria, within 4 weeks of randomization. Patients with pleural rinds not measurable by RECIST were eligible if disease was evaluable within 4 weeks of randomization using mesothelioma response criteria
- •May have undergone pleurodesis. If pleurodesis was performed, there must have been at least a 2-week delay before Pemetrexed administration. A CT must have been performed after 2 weeks after pleurodesis to serve as the baseline scan.
- •ECOG Performance Status of 0 or 1
- •Normal organ and marrow function, as defined by:
- •Absolute neutrophil count ≥ 1,500/ul
- •Platelet count ≥ 100,000/ul
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
- •Albumin ≥ 2.5 g/dL
- •Creatinine clearance ≥ 45 mL/min or Creatinine ≤ 2.0 g/dL
- •Age 18 years and over
- •Able to take folic acid and cyanocobalamin (vitamin B12)
- •Willing and able to take dexamethasone
- •Women of childbearing potential and sexually active men were required to use contraception during and for the first 3 months after the study
- •Exclusion Criteria
- •A candidate for curative surgery
- •Prior radiation therapy to the target lesion, unless the lesion was clearly progressing per RECIST criteria after prior radiation and the interval between the most recent radiation therapy and enrollment was at least 4 weeks
- •Prior systemic chemotherapy for mesothelioma. Prior intracavitary cytotoxic drugs or immunomodulators were not permitted, unless given for the purpose of pleurodesis.
- •Active infection or serious concomitant systemic disorder
- •Second primary malignancy, other than in situ malignancies or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 3 years previously with no evidence of recurrence.
- •Treatment with an investigational agent within 4 weeks before enrollment
- •Known or suspected brain metastases
- •Women must not be pregnant or breastfeeding
- •Obviously malnourished or with a weight loss of greater than 10% in the preceding 6 weeks
- •Aspirin or other nonsteroidal anti-inflammatory drugs for 2 days before, during, and for 2 days after each administration of pemetrexed disodium (5 days before, during, and 2 days after each administration of pemetrexed disodium for piroxicam, naproxen, diflunisal, or nabumetone)
排除标准
- 未提供
研究组 & 干预措施
Pemetrexed/Carboplatin
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to area under the curve (AUC) 5 IV over 30 minutes on day 1 of a 21-day cycle.
干预措施: pemetrexed disodium (Drug)
Pemetrexed/Carboplatin
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to area under the curve (AUC) 5 IV over 30 minutes on day 1 of a 21-day cycle.
干预措施: carboplatin (Drug)
Pemetrexed/Gemcitabine
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
干预措施: pemetrexed disodium (Drug)
Pemetrexed/Gemcitabine
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Best Overall Response by RECIST Criteria (Version 1.0)
时间窗: Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression
Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.
次要结局
- Progression-Free Survival(Assessed every 3 months for 2 years, then every 6 months for 1 year)
- Overall Survival(Assessed every 3 months for 2 years, then every 6 months for 1 year)