NCT00016926已完成2 期
A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 20
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 capecitabine in treating patients who have advanced, persistent, or recurrent cervical cancer.
详细描述
OBJECTIVES:
- Determine the activity of capecitabine in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix.
- Determine the toxicity profile of this drug in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed advanced, persistent, or recurrent squamous cell carcinoma of the cervix
- •Documented disease progression after local therapy and considered incurable
- •At least 1 target lesion measurable in at least 1 dimension
- •At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
- •Target lesion cannot be in a previously irradiated field
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine clearance at least 50 mL/min
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection requiring antibiotics
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No neuropathy (sensory and motor) greater than grade I
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior biologic therapy or immunotherapy for the malignant tumor
- •No concurrent prophylactic filgrastim (G-CSF)
- •Chemotherapy:
- •At least 3 weeks since prior chemotherapy for the malignant tumor and recovered
- •No prior cytotoxic therapy (except when used as a radiosensitizer)
- •No prior chemotherapy for other malignancy
- •Endocrine therapy:
- •At least 1 week since prior hormonal therapy for the malignant tumor
- •Concurrent hormone replacement therapy allowed
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy for the malignant tumor and recovered
- •No prior radiotherapy for other malignancy
- •Recovered from prior surgery
- •At least 3 weeks since any other prior therapy for the malignant tumor
- •No prior anticancer therapy that contraindicates study therapy
- •No concurrent amifostine or other protective reagents
排除标准
- 未提供
研究者
研究点 (20)
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