Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 98
- 主要终点
- Probability of Complete Clinical Response
研究概览
简要总结
This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma.
II. To evaluate the value of inhibin for predicting response.
OUTLINE:
Patients receive paclitaxel intravenously (IV) over 3 hours on day 1. Treatment continues every 21 days 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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor [androblastoma], steroid [lipid] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex cord tumor with annular tubules)
- •Patients must have recurrent stromal tumor having received no more than one prior chemotherapy regimen
- •Patients must have measurable disease as defined by Gynecological Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •White blood count equal to or greater than 3000/mcl
- •Granulocyte count equal to or greater than 1500/mcl
- •Platelet count equal to or greater than 100,000/mcl
- •Creatinine equal to or less than 2.0 mg%
- •Bilirubin less than or equal to 1.5 times normal
- •Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times normal
- •Patients with a GOG performance grade of 0, 1 or 2
- •Patients of child bearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control
- •Patients who have met the pre-entry requirements as specified
- •Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
排除标准
- •Patients with GOG performance grade of 3 or 4
- •Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy
- •Patients having received more than one prior chemotherapy regimen
- •Patients amenable to cure by surgery
- •Patients with prior radiation except for those whose recurrent disease is outside the radiation port
研究组 & 干预措施
Treatment (paclitaxel)
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Probability of Complete Clinical Response
时间窗: Up to 5 years
The probability of complete clinical response (i.e. proportion of participants) (assessed using GOG RECIST criteria) of paclitaxel as second line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma
次要结局
- Progression-free Survival(The period from study entry until disease progression, death or date of last contact)
- Overall Survival(The observed length of life from entry into the study to death or the date of last contact)