Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 12
- 主要终点
- Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
研究概览
简要总结
The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.
详细描述
Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.
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
- •≥ 18 years of age
- •high risk uterine LMS, FIGO stage I or II
- •pathology review of LMS high grade and /or mitotic rate greater than or equal to 5 mitoses/10 hpf
- •no longer than 12 weeks from surgical resection of cancer
- •no evidence of residual disease
- •ECOG 0 or 1
- •ANC ≥ 1,500, hemoglobin ≥ 8.0, platelets ≥100,000
- •creatinine ≤ 1.5 x institutional upper limits of normal
- •adequate liver function
- •neuropathy (sensory and motor) ≤ CTC grade 1
- •negative pregnancy test
- •signed consent
排除标准
- •patients with other invasive malignancies
- •prior therapy with gemcitabine or docetaxel or doxorubicin
- •hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •women who are breast feeding
- •cardiac ejection fraction <50%
- •prior pelvic irradiation
- •treatment with hormone replacement or anti-hormonal agents or other cytotoxic agents
研究组 & 干预措施
gemcitabine/docetaxel then doxorubicin
Gemcitabine 900 mg/m2 IV over 90 minutes days 1 and 8 Docetaxel 75 mg/m2 IV day 8 (pre-medication dexamethasone 4-8 mg p.o. bid for 3 days, starting 12-24 hours prior to docetaxel). Doxorubicin 60 mg/m2 IVP every 21 days for 4 cycles (recommend use of central venous catheter access).
干预措施: gemcitabine, docetaxel, doxorubicin (Drug)
结局指标
主要结局
Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
时间窗: Every 3 months up to two years
次要结局
- Correlation Between Age and Tumor Response to Treatment (PFS)(2 years)
- Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)(2 years)
- Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)(2 years)
- Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)(2 years)
- Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)(2 years)
- Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)(2 years)
- Tolerability/Toxicity of This Regimen(Every 28 days during dosing and then every 3 months thereafter until patient comes off study)
- Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)(2 years)
- Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)(2 years)