A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
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
- Progression-free Survival (PFS) > 6 Months
研究概览
简要总结
This phase II trial is studying how well thalidomide works in treating patients with carcinosarcoma of the uterus that has come back or that does not go to remission (decrease or disappear but may still be in the body) despite treatment. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
详细描述
OBJECTIVES: Primary I. Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine carcinosarcoma.
II. Determine the nature and degree of toxicity of this drug in these patients.
Secondary I. Determine the partial and complete response rates in patients treated with this drug.
II. Determine the duration of PFS and overall survival of patients treated with this drug.
III. Determine the effect of this drug on initial performance status and histological grade in these patients.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed uterine sarcoma
- •Carcinosarcoma (malignant mixed müllerian tumor)
- •Homologous or heterologous type
- •Recurrent or persistent with documented disease progression after prior local therapy
- •At least 1 unidimensionally measurable target lesion
- •At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI
- •At least 10 mm by spiral CT scan
- •Tumors within a previously irradiated field are considered non-target lesions
- •Must have received 1 prior initial chemotherapy regimen (including high-dose ,consolidation, or extended therapy after surgical or nonsurgical assessment) for carcinosarcoma
- •No documented brain metastases since diagnosis of cancer
- •Patients with stable CNS deficits are allowed provided that there is no evidence of brain metastases on CT scan or MRI
- •Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), including any active phase III GOG protocol for the same patient population
- •Performance status - GOG 0-2 if received 1 prior therapy regimen
- •Performance status - GOG 0-1 if received 2 prior therapy regimens
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Creatinine clearance greater than 60 mL/min
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use at least 1 highly active method of contraception and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study participation
- •No seizure disorders since diagnosis of cancer
- •Patients with a history of seizure disorders are allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months) while on an appropriately monitored treatment regimen
- •No active infection requiring antibiotics
- •No greater than grade 1 sensory or motor neuropathy
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •At least 3 weeks since prior immunologic agents for uterine sarcoma
- •No prior thalidomide
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy for uterine sarcoma and recovered
- •No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent uterine sarcoma
- •No prior non-cytotoxic chemotherapy for recurrent or persistent uterine sarcoma
- •No concurrent bisphosphonates (e.g., zoledronate)
- •At least 1 week since prior hormonal therapy for uterine sarcoma
- •Concurrent hormone replacement therapy allowed
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy for uterine sarcoma and recovered
- •No prior radiotherapy to more than 25% of marrow-bearing areas
- •See Disease Characteristics
- •Recovered from prior surgery
- •At least 3 weeks since any other prior therapy for uterine sarcoma
- •No prior anticancer therapy that would preclude study
排除标准
- 未提供
研究组 & 干预措施
Treatment (thalidomide)
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (thalidomide)
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Thalidomide (Drug)
结局指标
主要结局
Progression-free Survival (PFS) > 6 Months
时间窗: Every other cycle for 6 months
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0
时间窗: Each cycle during treatment and 30 days after the last treatment (average 4 months)
次要结局
- Progression Free Survival(Every other cycle until progression or death, up to 5 years.)
- Tumor Response(For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. (average = 4 months))
- Overall Survival(From study entry to death or last contact, up to 5 years.)
- Initial Performance Status(baseline)
- Initial Histologic Grade(Baseline)