A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Therapy Completion Rate
研究概览
简要总结
The main purpose of this trial is to look at how elderly women (70 years of age or older) with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or responds to standard carboplatin and paclitaxel chemotherapy.
详细描述
OBJECTIVES:
Primary
•To determine the completion rate of six cycles of carboplatin/paclitaxel with no dose reductions because of toxicities.
Secondary
- Assess cancer antigen 125 (CA125) response rates of paclitaxel/carboplatin in this group of patients
- Assess significant toxicities in this group of patients and compare to a non-elderly population.
- To determine which clinical parameters will predict lack of completion of six cycles of carboplatin and paclitaxel chemotherapy.
- Assess quality of life changes during chemotherapy and up to one year after completion of chemotherapy.
- Assess progression-free survival and overall survival for this group.
- To determine the feasibility of accrual.
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
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 70 or older
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 and is medically eligible and clinically appropriate to receive systemic chemotherapy
- •Diagnosis of ovarian, primary peritoneal, fallopian tube cancer, papillary serous cancer of the endometrium, or mixed mesodermal tumors of the ovary, fallopian tube or uterus
- •Life expectancy greater than 6 months
- •Baseline laboratory values as described in protocol
排除标准
- •Active infection requiring antibiotics at the time of starting chemotherapy
- •Prior pelvic radiotherapy > 25% of bone marrow
- •Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs
- •Past history of bone marrow transplantation or stem cell support
- •Known history of central nervous system (CNS) metastasis
- •History of prior malignancy that required prior systemic therapy
- •Clinically significant cardiac disease
- •Uncontrolled diabetes mellitus
- •Any signs of intestinal obstruction
- •Participation in an investigational drug study within three weeks prior to study entry
- •History of psychiatric disability or other central nervous system disorder
研究组 & 干预措施
Carboplatin/Paclitaxel
Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
干预措施: Paclitaxel (Drug)
Carboplatin/Paclitaxel
Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Therapy Completion Rate
时间窗: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.
次要结局
未报告次要终点
研究者
Ursula A. Matulonis, MD
Medical Oncologist
Dana-Farber Cancer Institute