NCT01085630已完成2 期
Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 145
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.
详细描述
OBJECTIVES:
Primary
- To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin.
Secondary
- To determine the overall survival of patients treated with this regimen versus observation.
- To evaluate the frequency of responses in patients treated with this regimen.
- To assess the toxicity of this regimen in these 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
- 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 confirmed malignant pleural mesothelioma meeting 1 of the following cell types:
- •Epithelial
- •Sarcomatoid
- •Mixed type
- •Histologically documented malignant pleural mesothelioma, epithelial, sarcomatoid or mixed type, not amenable to surgical resection
- •Prior treatment
- •Currently receiving first-line treatment with pemetrexed + platinum; patients are to be registered to Cancer and Leukemia Group B (CALGB) 30901 no later than the last day of cycle 4 of first line therapy
- •Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) are acceptable; prior intrapleural cytotoxic chemotherapy will not be considered systemic chemotherapy
- •Prior surgical treatment is allowed
- •Prior radiation therapy is allowed
- •Non-pregnant and non-nursing; women of child bearing potential and men must agree to use an appropriate method of birth control throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier methods (diaphragm plus condom)
- •RANDOMIZATION ELIGIBILITY CRITERIA
- •Patients with complete response, partial response, or stable disease following 4, 5 or 6 cycles of first-line chemotherapy with pemetrexed AND either cisplatin or carboplatin; a maximum of 6 cycles of chemotherapy may have been given
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Granulocytes >= 1,500/ul
- •Platelet count >= 100,000/ul
- •Total bilirubin =< 1.5 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2 x ULN
- •Calculated creatinine clearance >= 45 ml/min
- •Disease not amenable to surgery
- •Must be enrolled on imaging protocol CALGB-580903
- •Complete response, partial response, or stable disease after completion of 4 courses of first-line chemotherapy comprising pemetrexed disodium AND cisplatin or carboplatin
- •Study therapy will begin within 9 weeks following day 1 of cycle 4 of first-line treatment
- •No clinically significant pleural or peritoneal effusions that cannot be adequately managed by drainage before or during pemetrexed disodium
- •PATIENT CHARACTERISTICS:
- •ECOG performance status of 0-1
- •Life expectancy ≥ 12 weeks
- •Granulocytes ≥ 1,500/μL
- •Platelet count ≥ 100,000/μL
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST ≤ 2 times ULN
- •Creatinine clearance ≥ 45 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No psychiatric illness that would prevent the patient from giving informed consent
- •No second malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless curatively treated with no evidence of active disease for ≥ 5 years
- •No medical conditions that, in the opinion of the treating physician, would make study treatment unreasonably hazardous for the patient including, but not limited to, the following:
- •Ongoing or active infection such as HIV positivity
- •Inability to take oral medications
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed
- •Prior intrapleural cytotoxic chemotherapy not considered systemic chemotherapy
- •Prior surgery allowed
- •Prior radiotherapy allowed
- •No concurrent palliative radiotherapy
- •No concurrent hormones or other chemotherapeutic agents except for the following:
- •Steroids for adrenal failure
- 另有 2 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: pemetrexed disodium (Drug)
Arm II
Active Comparator
Patients undergo observation until disease progression.
干预措施: clinical observation (Other)
结局指标
主要结局
Progression-free Survival
时间窗: Baseline up to 3 years
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
次要结局
- Overall Survival(Baseline up to 3 years)
- Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)(Baseline up to 3 years)
- Response Rate(Up to 3 years)
研究者
研究点 (145)
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