A Phase II Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 60
- 主要终点
- Antitumor activity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or recurrent uterine leiomyosarcoma.
详细描述
OBJECTIVES:
- Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or pegfilgrastim in patients with advanced, persistent, or recurrent uterine leiomyosarcoma.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 9-15 OR pegfilgrastim SC on day 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed uterine leiomyosarcoma
- •Advanced, persistent, or recurrent disease
- •Documented disease progression
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •At least 1 target lesion
- •Tumors within a previously irradiated field are considered nontarget lesions
- •Ineligible for higher priority GOG protocols (i.e., any active phase III GOG protocol for the same patient population)
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No neuropathy (sensory or motor) > grade 1
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No active infection requiring antibiotics
- •No known hypersensitivity to E. coli-derived proteins
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior cytotoxic chemotherapy for the malignancy
- •Endocrine therapy
- •At least 1 week since prior hormonal therapy for the malignancy
- •Concurrent hormone replacement therapy allowed
- •Radiotherapy
- •See Disease Characteristics
- •Recovered from prior radiotherapy
- •Recovered from prior surgery
- •Recovered from all other prior therapy
- •No prior cancer treatment that would preclude study treatment
- •No concurrent amifostine or other protective agents
排除标准
- 未提供
结局指标
主要结局
Antitumor activity
Toxicity
次要结局
未报告次要终点