NCT00811408Unknown1 期
Modulating the Expression of Oncoproteins of Papillomavirus (HPV) to Increase Radiosensitivity: a Phase I Study of Antiviral Agent Cidofovir and Chemoradiotherapy Therapy in Cervical Cancers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose of cidofovir
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as cidofovir may make tumor cells more sensitive to radiation therapy. Giving cidofovir together with radiation therapy and chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cidofovir in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer who are receiving chemotherapy together with radiation therapy.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of cidofovir when given as a radiosensitizer in patients with stage IB-IVA cervical cancer undergoing concurrent chemoradiotherapy.
Secondary
- Evaluate the influence of treatment on the expression of mRNA codons in HPV oncoproteins E6 and E7.
- Determine the rate of local control.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix
- •Stage IB2 (> 4 cm), II, III, or IVA disease
- •No lumbo-aortic metastasis
- •Initial tumor must be HPV-positive
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Life expectancy > 3 months
- •ANC > 2,000/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •Transaminases < 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase < 1.5 times ULN
- •Bilirubin < 1.5 times ULN
- •Creatinine < 1.5 times ULN
- •Creatinine clearance ≥ 55 mL/min
- •Proteinuria < 2 g/L
- •Not pregnant
- •Negative pregnancy test
- •No renal disease
- •No concurrent active infection
- •No prior or concurrent psychiatric illness
- •No history of cancer except for basal cell carcinoma
- •No other active infection or serious illness that would prevent the patient from receiving study treatment
- •No known psychological, familial, social, or geographic reason that would preclude clinical monitoring
- •PRIOR CONCURRENT THERAPY:
- •No prior radiotherapy or chemotherapy
- •More than 30 days since prior experimental drugs
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of cidofovir
次要结局
未报告次要终点
研究者
研究点 (2)
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