A Phase II Evaluation of CCI-779 (Temsirolimus, NCI-Supplied Agent, NSC #683864, IND #61010) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 6 Month Progression-free Survival (PFS)
研究概览
简要总结
This phase II trial is studying the side effects and how well temsirolimus works in treating patients with refractory or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
OBJECTIVES: Primary I. Determine the 6-month progression-free survival (PFS) or objective tumor response in patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with temsirolimus.
II. Determine the toxicity of this drug in these patients.
Secondary I. Determine the duration of PFS and overall survival of these patients.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive temsirolimus 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.
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 ovarian epithelial, fallopian tube or primary peritoneal cavity cancer
- •Recurrent or refractory
- •Prior treatment with ≥ 1 platinum-based chemotherapeutic regimen for management of primary disease (containing carboplatin, cisplatin, or another organoplatinum compound) required
- •Initial treatment may have included any of the following:
- •High-dose therapy
- •Intraperitoneal therapy
- •Consolidation therapy
- •Noncytotoxic agents
- •Extended therapy administered after surgical or nonsurgical assessment
- •Patients must meet ≥ 1 of the following criteria:
- •Treatment-free interval after platinum therapy of < 12 months for patients who received only 1 platinum-based regimen
- •Progressed during platinum-based therapy
- •Refractory disease after a platinum-based regimen
- •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
- •Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy
- •Not eligible for a higher priority GOG protocol, if one exists
- •GOG performance status (PS) 0-2 for patients who have receive one prior regimen OR GOG PS 0-1 for patients who have received 2-3 prior regimens
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine ≤ 1.5 times upper limit normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •AST ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •No neuropathy (sensory and motor) > grade 2
- •Fasting cholesterol < 350 mg/dL
- •Fasting triglycerides < 400 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection requiring antibiotics (with the exception of uncomplicated UTI)
- •No other invasive malignancies within the past 5 years, except for non-melanoma skin cancer, breast cancer, or head and neck cancer
- •See Disease Characteristics
- •Recovered from prior surgery, radiotherapy, or chemotherapy
- •At least 1 week since prior hormonal therapy directed at the malignant tumor
- •At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin
- •Patient must remain free of recurrent or metastatic disease
- •At least 3 years since prior adjuvant chemotherapy for localized breast cancer
- •Patient must remain free of recurrent or metastatic disease
- •At least 3 weeks since other prior therapy directed at the malignant tumor, including immunologic agents
- •No prior temsirolimus
- •No prior cancer treatment that would preclude study therapy
- •No prior radiotherapy to > 25% of marrow-bearing areas
- •No prior radiotherapy to any portion of the abdominal cavity or pelvis, except for the treatment of ovarian cancer
- •No prior non-cytotoxic therapy for management of recurrent or persistent ovarian disease, except for therapy that was part of the primary treatment regimen
- •Two additional cytotoxic regimens (defined as any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa) for management of recurrent or persistent ovarian disease allowed
- •Concurrent low molecular weight heparin allowed provided PT/INR ≤ 1.5
- •Concurrent hormone replacement therapy allowed
- •No concurrent amifostine or other protective reagents
- •No concurrent prophylactic filgrastim (G-CSF)
排除标准
- 未提供
研究组 & 干预措施
Treatment (temsirolimus)
Patients receive temsirolimus 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.
干预措施: temsirolimus (Drug)
结局指标
主要结局
6 Month Progression-free Survival (PFS)
时间窗: 6 months
Number of participants who survived progression-free for more than 6 months.
Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
时间窗: Up to 5 years
Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions.
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
时间窗: Up to 5 years
次要结局
- Duration of Overall Survival(Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.)
- Duration of Progression-free Survival(CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months up to 5 years)