A Phase II Evaluation of Combination Bevacizumab (NCI-Supplied Agent: NSC #70486) and Temsirolimus (CCI-779, NCI-Supplied Agent, NSC #683864) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 41
- 主要终点
- Progression-free Survival at 6 Months
研究概览
简要总结
This phase II trial is studying the side effects of giving bevacizumab together with temsirolimus and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving bevacizumab together with temsirolimus may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To assess the activity of bevacizumab and temsirolimus, in terms of 6-month progression-free survival (PFS) and objective tumor response, in patients with recurrent or persistent endometrial cancer.
II. To determine the nature and degree of toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To determine the duration of PFS and overall survival of patients treated with this regimen.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed endometrial carcinoma (from primary tumor) including any of the following cell types:
- •Endometrioid adenocarcinoma
- •Serous adenocarcinoma
- •Undifferentiated carcinoma
- •Clear cell adenocarcinoma
- •Mixed epithelial carcinoma
- •Adenocarcinoma not otherwise specified
- •Mucinous adenocarcinoma
- •Squamous cell carcinoma
- •Transitional cell carcinoma
- •Mesonephric carcinoma
- •Recurrent or persistent disease that is refractory to curative therapy or established treatments
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- •Must have ≥ 1 target lesion to assess response as defined by RECIST
- •Tumors within a previously irradiated field are designated as "non-target" lesions in the absence of documented disease progression or a biopsy to confirm persistence for ≥ 90 days after completion of radiotherapy
- •Must have received 1 prior chemotherapeutic regimen for management of endometrial carcinoma
- •May have received 1 additional cytotoxic regimen for management of this disease
- •Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, including any active GOG Phase III protocol for patients with endometrial carcinoma
- •No history or evidence of CNS disease, including primary brain tumor or any brain metastases upon physical examination
- •GOG performance status (PS) 0-2 (for patients who have received 1 prior regimen) OR PS 0-1 (for patients who have received 2 prior regimens)
- •ANC ≥ 1,500/mcL
- •Platelet count ≥ 100,000/mcL
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •SGOT ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Urine protein:creatinine ratio < 1.0 OR urine protein < 1,000 mg by 24-hour urine collection
- •INR ≤ 1.5 OR in-range INR between 2 and 3 if patient is on a stable dose of therapeutic warfarin
- •PTT ≤ 1.5 times ULN
- •Fasting cholesterol < 350 mg/dL
- •Fasting triglycerides < 400 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Seizures allowed provided they are controlled with standard medical therapy
- •No active infection requiring antibiotics, except uncomplicated urinary tract infection
- •No active bleeding or pathologic conditions that carry high risk of bleeding, (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels)
- •No serious, non-healing wound, ulcer, or bone fracture, including abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 3 months
- •No prior underlying lesions that caused the fistula or perforation that have not been corrected
- •No prior interstitial pneumonitis
- •No clinically significant cardiovascular disease, including any of the following:
- •Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg
- •Myocardial infarction or unstable angina within the past 6 months
- •New York Heart Association class II-IV congestive heart failure
- •Serious cardiac arrhythmia requiring medication
- •Peripheral vascular disease ≥ grade 2
- •No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
- •No uncontrolled diabetes
- •Hemoglobin A1C < 10
- •No other invasive malignancies within the past 5 years, except nonmelanoma skin cancer and other specific malignancies (e.g., localized breast, head and neck, or skin cancer that completed treatment > 3 years prior to study and remain disease-free)
- 另有 20 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (bevacizumab, temsirolimus)
Patients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and 22.
干预措施: bevacizumab (Biological)
Treatment (bevacizumab, temsirolimus)
Patients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and 22.
干预措施: temsirolimus (Drug)
结局指标
主要结局
Progression-free Survival at 6 Months
时间窗: Every other cycle for 6 months
Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Tumor Response
时间窗: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
时间窗: Every cycle and 30 days after the last treatment, an average of 5 years.
次要结局
- Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade(Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease)
- Overall Survival(From entry into the study to death or the date of last contact, up to 5 years)
- Progression-free Survival at 6 Months by Performance Status(Every other cycle for 6 months)
- Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type(Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease)
- Progression-free Survival at 6 Months by Tumor Grade(Every other cycle for 6 months)
- Progression-Free Survival(Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.)
- Complete and Partial Tumor Response by RECIST 1.0 by Performance Status(Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease)
- Progression-free Survival at 6 Months by Histologic Type(Every other cycle for 6 months)