A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Chemotherapy Completion Rate
研究概览
简要总结
The purpose of this research study is to determine the feasibility and safety of giving the combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether or not this drug combined with radiation therapy works in treating women with Mullerian tumors of the uterus.
详细描述
OBJECTIVES:
Primary To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of Malignant Mixed Mullerian Tumors (MMMTs).
Secondary
* To describe the response rate by Response Evaluation Criteria in Solid Tumors
STATISTICAL DESIGN:
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
- •Surgically staged and histologically confirmed diagnosis of MMMT
- •18 years of age or older
- •ECOG Performance Score of 0-2
- •Adequate bone marrow function
- •Adequate renal function
- •Adequate hepatic function
- •Patients must be recovered from both the acute and late effects of any prior surgery
排除标准
- •Patients with an active infection
- •Patients with CNS metastases
- •History of prior malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin, or cervical intraepithelial neoplasia
- •Known hypersensitivity to any of the components of oxaliplatin or gemcitabine
- •Prior radiation to the pelvis
- •Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days
- •Peripheral neuropathy greater or equal to Grade 2
- •Stage IV visceral disease (lung and liver metastases at presentation)
- •Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent
- •Known HIV or Hepatitis B or C (active, previously treated or both)
- •Pregnant or breast feeding
研究组 & 干预措施
Oxaliplatin/ Gemcitabine Then Radiation
Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
干预措施: Gemcitabine (Drug)
Oxaliplatin/ Gemcitabine Then Radiation
Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
干预措施: Oxaliplatin (Drug)
Oxaliplatin/ Gemcitabine Then Radiation
Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
干预措施: Radiation (Radiation)
结局指标
主要结局
Chemotherapy Completion Rate
时间窗: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle
Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.
次要结局
- Radiation Therapy Completion Rate(Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.)
研究者
Susana M. Campos, MD
Medical Oncologist
Dana-Farber Cancer Institute