NCT01716689已完成2 期
Phase II Clinical Study of Metronomic Oral Cyclophosphamide in Elderly and/or Pre-treated Patients With Advanced Sarcomas
National Cancer Centre, Singapore1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Clinical benefit as defined by the composite of complete response (CR), partial response (PR) and stable disease (SD) lasting > 12 weeks per RECIST 1.1 as a measure of disease control
研究概览
简要总结
This is a single arm phase II clinical study to evaluate the efficacy and safety of metronomic oral cyclophosphamide in elderly and/or pre-treated patients with advanced sarcomas.
详细描述
Eligible patients will receive continuous metronomic oral cyclophosphamide at a dose of 50mg daily. Tumor assessments will be performed at baseline and every 6 weeks thereafter to assess response and disease progression. Toxicity will be monitored throughout treatment. The study's primary end point is defined as clinical benefit rate (CBR) at 12 weeks as a measure of disease control. The study is designed to distinguish a favorable true PFR of 40% from a null rate of 20% [Van Glabbeke et al. EJC 2002]. With a CBR of 40%, metronomic oral cyclophosphamide at this dose and schedule in this patient population will be considered worthy of further evaluation.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- •Participants must have histologically or cytologically confirmed, metastatic and/or unresectable high grade sarcoma for which standard multi-modality curative therapies do not exist or are no longer effective. Patients with low grade sarcoma need to additionally demonstrate disease progression in the last 6 months prior to study entry.
- •Age > 21 years
- •Prior anti-sarcoma chemotherapy
- •Participants who are 21 to 64 years of age at the time of study entry must have received at least one line of established chemotherapy, if such treatment exists; or refused such treatment, which includes either an anthracycline and/or ifosfamide. Patients whose sarcomas do not have known established therapy are eligible for this study without the requirement of a prior therapy.
- •Participants > 65 years of age at the time of study entry are eligible for this study without the requirement for prior treatment
- •ECOG performance status 0-3 (see Annex A)
- •Measurable disease outside of a prior irradiated area as defined by RECIST 1.1 guidelines. A lesion in a previously irradiated area is not eligible for measurable disease unless there is objective evidence of progression of the lesion prior to study enrollment
- •No limit to number of prior chemotherapies or biologics
- •Participants must have normal organ function as defined below:
- •Hemoglobin > 10g/dL
- •Absolute neutrophil count (ANC) > 1500/mm3
- •Platelet count > 75,000/mm3
- •Total bilirubin < 1.5 times institutional upper limits or normal (ULN)
- •AST/ALT < 3 times ULN (< 5 times ULN if hepatic involvement is present)
- •Creatinine < 1.5 times ULN. If creatinine is > 1.5 times ULN, a calculated creatinine clearance time (CCT) should be performed and patient would be eligible for study if the calculated CCT is > 10 mL/min.
- •[NB: Glomerular filtration rate (GFR) = [(140 - age) x weight [kg] x 1.22 ] / (serum creatinine [umol/L]. In women, multiply this result by 0.85
- •Resolution, or return to baseline of all clinically significant toxicities related to prior therapies
- •Patients must be suitable for oral drug administration
- •Willingness to use effective means of birth control throughout the duration of clinical study and for at least 3 months after completion of study drug
- •Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of study drug administration
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- •Patients diagnosed with gastrointestinal stromal tumor (GIST)
- •Participants who have had systemic anti-cancer therapy within 3 weeks of study entry (8 weeks for nitrosoureas or mitomycin C)
- •Palliative radiotherapy or major surgery within 3 weeks of study entry
- •Concurrent use of any other anti-cancer therapies or study agents
- •Symptomatic or uncontrolled brain or central nervous system metastases
- •Participants may not be receiving any other concomitant investigational agents
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR other primary malignancy is neither currently clinically significant nor requiring active intervention.
研究组 & 干预措施
Patients with advanced sarcoma
Experimental
干预措施: oral cyclophosphamide (Drug)
结局指标
主要结局
Clinical benefit as defined by the composite of complete response (CR), partial response (PR) and stable disease (SD) lasting > 12 weeks per RECIST 1.1 as a measure of disease control
时间窗: 24 months
次要结局
- Assessment of progression free survival(24 months)
- Assessment of objective response rate (ORR)(24 months)
- Assessment on duration of response to oral metronomic cyclophosphamide in patients who exhibit objective responses(24 months)
研究者
研究点 (1)
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