A Trial of CCI-779 in Patients With Soft Tissue Sarcoma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
研究概览
简要总结
This phase II trial is studying how well CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. To assess the antitumor activity of CCI-779 in this patient population.
SECONDARY OBJECTIVES:
I. To assess the following in patients with soft tissue sarcomas and following treatment with CCI-779: duration of response, time to progression, survival.
TERTIARY OBJECTIVES:
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
- •Histologically or cytologic confirmed soft tissue sarcoma
- •Measurable disease; for patients having only lesions measuring at least 1 cm to less than 2 cm, must use spiral CT imaging for both pre- and post-treatment tumor assessments
- •Absolute neutrophil count (ANC) >= 1,500/μL
- •Platelets (PLTS) >= 100,000/μL
- •Hgb >= 10.0 g/dL
- •Direct bilirubin =< 1.5 x ULN (upper limit normal)
- •AST(SGOT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present
- •ALT(SGPT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present
- •Creatinine =< 1.5 x ULN, or if greater, creatinine clearance >= 50 mL/min/1.73 m^2
- •Baseline glucose levels
- •Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L)
- •Fasting triglycerides =< 400 mg/dL (4.56 mmol/L)
- •ECOG Performance Status (PS) 0, 1 or 2
- •Life expectancy >= 12 weeks
- •Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
排除标准
- •Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- •Pregnant women
- •Breast-feeding women
- •Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception ( diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
- •Any of the following:
- •Nitrosoureas or mitomycin =< 6 weeks prior to study entry
- •Other chemotherapy =< 4 weeks prior to study entry
- •Radiotherapy =< 4 weeks prior to study entry
- •Concurrent use of any other investigation agent
- •Adverse events due to agents administered =< 4 weeks prior to study entry
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, diabetes, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Known HIV-positive patients receiving combination anti-retroviral therapy
- •Prior chemotherapy for metastatic disease
- •Exceptions:
- •Patients with GIST who fail Gleevec are eligible
- •Patients who have had adjuvant/neoadjuvant chemotherapy are also eligible
- •Known brain metastases
- •Exception: Patients with treated brain metastatic disease with stable symptoms after treatment for >= 1 month
研究组 & 干预措施
Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.
干预措施: temsirolimus (Drug)
Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
时间窗: Up to 6 months (6 courses)
次要结局
- Survival time(Time from registration to death due to any cause, assessed up to 5 years)
- Time to disease progression(Time from registration to documentation of disease progression, assessed up to 5 years)
- Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented(Up to 5 years)
- Time to treatment failure(Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years)