NCT00006471已完成2 期
A Phase II Study of Fenretinide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- To determine the response rate, time to progression, median survival, and percent one-year survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent or metastatic head and neck cancer.
详细描述
OBJECTIVES:
- Determine the response rate, time to progression, median survival, and percent of 1-year survival in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with fenretinide.
- Determine the pharmacokinetics and safety of this drug in these patients.
OUTLINE: Patients receive oral fenretinide every 12 hours on days 1-7. Treatment repeats every 3 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response continue treatment for 1 year.
PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven recurrent squamous cell carcinoma of the head and neck
- •Stage 4 disease, either at initial presentation or at recurrence. Patients with metastatic disease at initial presentation must have received at least one prior course of cytotoxic chemotherapy.
- •Patients who present with metastatic disease should have received no more than one prior regimen of chemotherapy or biologic therapy to be eligible. Patients who initially received adjuvant or induction chemotherapy and then recurred may have received one additional cycle of chemotherapy or biologic therapy at the time of recurrence. Patients may have received any number of cycles of a particular regimen of chemotherapy.
- •Patients must have a life expectancy of at least 3 months
- •Biopsy of the recurrent lesion(s) is encouraged but not mandatory for enrollment.
- •Performance status grade 0-
- •Serum creatinine <= 1.5 mg/dL.
- •Serum transaminases and bilirubin <= 1.5 time normal.
- •Age >= 18 years.
- •White blood cell count >= 3,000; platelets >= 100,000; hemoglobin >= 9mg/dl.
- •Signed informed consent.
- •Women of childbearing potential must agree to utilize two methods of effective birth control, one barrier, one hormonal, or should abstain from sexual intercourse that could result in pregnancy. Contraceptive measures should be continued for at least one month after fenretinide administration has been discontinued.
- •It is recommended that male patients with female partners of childbearing potential use barrier contraception while on fenretinide.
排除标准
- •Pregnant women (women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrollment in the study); women who are currently breast-feeding.
- •Grade 2 or greater peripheral neuropathy
- •Concurrent treatment with cytotoxic chemotherapy or radiation
- •Serious infection or other intercurrent illness requiring immediate therapy.
- •Inability to take oral medications, or other medical or social factors interfering with compliance.
- •Patients on high dose synthetic or natural Vitamin A derivatives (>= 10,000 per day).
- •Patients should not take any anti-oxidants such as Vitamin C or E.
研究组 & 干预措施
Fenretinide
Experimental
干预措施: Fenretinide (Drug)
结局指标
主要结局
To determine the response rate, time to progression, median survival, and percent one-year survival
时间窗: one-year survival
To determine the response rate, time to progression, median survival, and percent one-year survival.
次要结局
未报告次要终点
研究者
研究点 (1)
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