NCT01215136终止2 期
Phase II Trial of Everolimus or Everolimus Plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma: Hoosier Cancer Research Network GU10-147
Matthew Galsky11 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 11
- 主要终点
- Response Rate of Single-Agent Everolimus and Everolimus + Paclitaxel
研究概览
简要总结
The purpose of this trial is to explore the activity and safety of everolimus +/- paclitaxel as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma.
详细描述
OUTLINE: This is a multi-center study
Patients will be enrolled into one of two parallel cohorts:
- Cohort 1: impaired renal function AND poor performance status (cycle length = 28 days). Everolimus 10 mg orally daily
- Cohort 2: impaired renal function OR poor performance status (cycle length = 28 days). Everolimus 10 mg orally daily + IV Paclitaxel 80 mg/m2 on D1, 8, 15
Restaging evaluations will be performed after every 2 cycles.
Treatment will continue until disease progression or unacceptable toxicity.
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
- •Histological or cytological proof of transitional cell carcinoma (TCC) of the bladder, urethra, ureter, or renal pelvis (urothelial carcinoma). Histology may be mixed, but still requires a component of TCC.
- •Measurable disease according to RECIST and obtained by imaging within 30 days prior to registration for protocol therapy.
- •Must be ineligible for cisplatin, based on the following, within 30 days prior to registration for protocol therapy.
- •Prior radiation therapy is allowed to < 25% of the bone marrow.
- •Written informed consent and HIPAA authorization for release of personal health information.
- •Age > 18 years at the time of consent.
- •Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation.
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to prior to registration for protocol therapy.
- •Females must not be breastfeeding.
排除标准
- •No prior chemotherapy for metastatic disease. Prior chemotherapy in the neoadjuvant/adjuvant setting is allowed if completed at least 12 months prior to registration for protocol therapy.
- •No active CNS metastases or leptomeningeal metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis.
- •No prior malignancy is allowed except for adequately treated basal cell or adequately treated squamous cell skin cancer, in situ cervical cancer, Gleason ≤ grade 7 prostate cancers (treated definitively with no evidence of PSA progression), or other cancer for which the patient has been disease-free for at least 5 years.
- •No treatment with any anticancer therapy or investigational agent within 30 days prior to registration for protocol therapy.
- •No known hypersensitivity to any protocol treatment.
- •No prior treatment with mTOR inhibitor (sirolimus, temsirolimus, everolimus).
- •No history of immunization with attenuated live vaccines within one week prior to registration for protocol therapy or during study period.
- •No severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air.
- •No uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN.
- •No active (acute or chronic) or uncontrolled severe infections.
- •No liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
- •No known history of HIV seropositivity.
- •No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
- •No active, bleeding diathesis.
- •No history of major surgery (defined as requiring general anesthesia) or significant traumatic injury within 30 days prior to registration for protocol therapy.
研究组 & 干预措施
Cohort 1
Active Comparator
Single-agent everolimus (enrollment limited to patients with patients with creatinine clearance < 60 ml/min AND Karnofsky performance status of 60-70%)
干预措施: Everolimus (Drug)
Cohort 2
Active Comparator
Everolimus plus paclitaxel (enrollment limited to patients with creatinine clearance < 60 ml/min OR Karnofsky performance status of 60-70%)
干预措施: Everolimus (Drug)
Cohort 2
Active Comparator
Everolimus plus paclitaxel (enrollment limited to patients with creatinine clearance < 60 ml/min OR Karnofsky performance status of 60-70%)
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Response Rate of Single-Agent Everolimus and Everolimus + Paclitaxel
时间窗: 4 months
To evaluate clinical benefit rate (complete response, partial response, and stable disease) at 4 months from initiation of treatment.
次要结局
- Number of Adverse Events as a Measure of Safety and Tolerability(5 months)
- Progression Free Survival(4 months)
- Overall Survival(12 months)
研究者
Matthew Galsky
Sponsor-Investigator
Hoosier Cancer Research Network
研究点 (11)
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