A Phase II Evaluation of Docetaxel and Gemcitabine Plus G-CSF in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Frequency of severity of observed adverse effects assessed using CTC version 2.0
研究概览
简要总结
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus.
详细描述
PRIMARY OBJECTIVES:
I. Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or pegfilgrastim in patients with persistent or recurrent uterine leiomyosarcoma.
II. Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE:
Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and filgrastim (G-CSF) subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks 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 uterine leiomyosarcoma
- •Recurrent or persistent disease that is refractory to curative therapy or established treatments
- •Must have received 1 prior chemotherapy regimen that may include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques
- •At least 10 mm by spiral CT scan
- •Lesions within a previously irradiated field allowed provided progression is documented or biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- •Ineligible for a high priority GOG protocol
- •Performance status - GOG 0-2
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.1 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
- •No active infection requiring antibiotics
- •No motor or sensory neuropathy greater than grade 1
- •No other malignancy within the past 5 years except nonmelanoma skin cancer
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) for recurrent or persistent disease
- •At least 3 weeks since prior biologic or immunologic therapy for this disease
- •See Disease Characteristics
- •See Biologic therapy
- •At least 3 weeks since prior chemotherapy and recovered
- •No prior docetaxel or gemcitabine
- •No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial regimens
- •No prior chemotherapy for another malignancy that would preclude study
- •At least 1 week since prior hormonal therapy for this disease
- •Concurrent hormone replacement therapy allowed
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy and recovered
- •See Disease Characteristics
- •Recovered from prior recent surgery
- •At least 3 weeks since other prior therapy for this disease
- •No concurrent amifostine or other protective agents
排除标准
- 未提供
研究组 & 干预措施
Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)
Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and G-CSF SC on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Docetaxel (Drug)
Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)
Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and G-CSF SC on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Filgrastim (Biological)
Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)
Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and G-CSF SC on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Gemcitabine Hydrochloride (Drug)
Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)
Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and G-CSF SC on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Pegfilgrastim (Biological)
结局指标
主要结局
Frequency of severity of observed adverse effects assessed using CTC version 2.0
时间窗: Up to 5 years
The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.
Frequency and duration of objective response
时间窗: Up to 5 years
次要结局
未报告次要终点