NCT00098995已完成1 期
A Phase I Study Of Tirapazamine In Combination With Radiation And Weekly Cisplatin In Patients With Locally Advanced Cervical Cancer
Peter MacCallum Cancer Centre, Australia4 个研究点 分布在 2 个国家目标入组 22 人开始时间: 2004年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose of tirapazamine
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as tirapazamine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Tirapazamine may help cisplatin kill more tumor cells by making tumor cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Tirapazamine may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy in different ways together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of tirapazamine when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and the recommended phase II and III dose of tirapazamine when combined with cisplatin and radiotherapy in patients with Stage IB-IVA squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine failure-free survival of patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Determine time to locoregional failure in patients treated with this regimen.
- Determine patterns of failure for the site of first failure in patients treated with this regimen.
- Determine the 12-week post-treatment complete response rate in patients treated with this regimen.
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 or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix
- •Stage IB, IIA, IIB, III, or IVA disease
- •No evidence of involvement of para-aortic nodes by CT scan, MRI, fluorodeoxyglucose positron emission tomography, or lymphadenectomy
- •Involvement of common iliac nodes allowed
- •No evidence of distant metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 6 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin < 1.25 times upper limit of normal (ULN)
- •AST and ALT ≤ 3 times ULN
- •Calculated creatinine clearance ≥ 60 mL/min OR
- •Glomerular filtration rate ≥ 60 mL/min
- •Cardiovascular
- •No significant cardiac disease that would preclude IV fluid load required for administration of cisplatin
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No symptomatic peripheral neuropathy ≥ grade 2
- •No clinically significant sensori-neural hearing impairment interfering with activities of daily living or requiring a hearing aid
- •Audiometric changes alone of any severity allowed
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to tirapazamine or cisplatin
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other concurrent uncontrolled illness
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent epoetin alfa
- •No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
- •No concurrent pegfilgrastim
- •Chemotherapy
- •No prior chemotherapy for another malignancy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior pelvic or abdominal radiotherapy for another malignancy
- •No prior radiotherapy to ≥ 15% of bone marrow-bearing areas
- •No concurrent intensity-modulated radiotherapy
- •No concurrent interstitial brachytherapy
- •Not specified
- •No prior treatment for invasive cervical cancer
- •No other concurrent therapeutic investigational agents
- 另有 4 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of tirapazamine
Safety and tolerability
次要结局
- Failure-free survival
- Overall survival
- Patterns of failure for the site of first failure (local-regional, distant, or both)
- Complete response rate at 12 weeks following study completion
- Hypoxia by 18F-azomycinarabinoside (FAZA) PET scan at baseline and 12 wks following completion of radiotherapy correlated w/ obj. tumor response by PET- fludeoxyglucose F 18 (FDG) and local-regional failure
研究者
研究点 (4)
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