NCT00383266终止2 期
A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a study of an investigational agent, pemetrexed, in combination with a standard chemotherapy drug, carboplatin, for treatment of patients with metastatic esophageal cancer.
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
- •Patients must have a histologically or cytologically proven metastatic or recurrent esophageal cancer. Both adenocarcinoma and squamous carcinoma are eligible for the study. Patients with small cell carcinoma or sarcoma of the esophagus are not eligible for the study.
- •Patients may have had no prior chemotherapy treatment for metastatic esophageal cancer. Patients may have had chemotherapy with 5-FU combined with definitive radiotherapy for curative intent in the adjuvant, neoadjuvant, or definite setting for locally advanced esophageal cancer, if no less than one year prior to trial enrollment. Patients may not have received pemetrexed in the past.
- •Patients who have had radiotherapy for esophageal cancer must have completed radiotherapy at least four weeks prior to entry in the study.
- •Patients need to have measurable disease.
- •Lesions that are not considered measurable include the following:
- •Bone lesions
- •Brain metastases or 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 of >=12 weeks.
- •Patients must have adequate bone marrow function defined as: white blood cells (WBC) >= 3000/mm^3, absolute neutrophil count (ANC) >= 1,500/mm^3, hemoglobin >= 9.0 g/dL, and platelet count >= 100,000/mm^
- •Patients must have adequate liver function defined as: Bilirubin <= 1.5 x institutional normal and ALT/AST < 3 x institutional normal.
- •Patients must have adequate renal function defined as: serum creatinine <= 3.0 mg/dL and creatinine clearance >= 45 mL/min.
- •Radiation therapy for brain metastases should be completed at least four weeks prior to enrollment to this protocol.
- •Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or uncontrolled symptomatic cardiac arrhythmia.
- •Patients must be able to be compliant with premedications of dexamethasone, folic acid, and vitamin B
- •For all sexually active women of child-bearing age, the use of adequate contraception (hormonal or barrier method of birth control) will be required prior to study entry and for the duration of study participation.
- •Age >= 18 years.
- •Written consent.
- •Ibuprofen (400 mg qid) can be administered with Alimta in patients with normal renal function (creatinine clearance > 80 mL/min
排除标准
- •Patients with third-space fluid (pleural effusions, ascites, etc.) uncontrolled by drainage.
- •Pregnant or nursing females
- •Patients who have had pre-existing neuropathy greater than or equal to grade
- •Patients with known active CNS metastases.
研究组 & 干预措施
Pemetrexed + Carboplatin
Experimental
- Pemetrexed 500 mg/m^2 IV over 10 minutes
- Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
- Each cycle will last 21 days.
干预措施: Pemetrexed (Drug)
Pemetrexed + Carboplatin
Experimental
- Pemetrexed 500 mg/m^2 IV over 10 minutes
- Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
- Each cycle will last 21 days.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Until patient progresses or dies (median follow-up 293 days -- range (63-632 days)
* Overall response rate = complete response (CR) + partial response (PR) using RECIST. * CR=disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level * PR=at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD
次要结局
- Time to Disease Progression(Until patient progresses (median follow-up 293 days -- range (63-632 days))
- Overall Survival Rate(2 years)
- Toxicities(30 days following completion of treatment (maximum number of cycles = 6))
- Overall Survival (OS)(Until patient's death (median follow-up 293 days -- range (63-632 days)))
研究者
研究点 (1)
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