A Phase I/II Study Of COX-2 Inhibitor, CELEBREX (CELECOXIB), And Chemoradiation In Patients With Locally Advanced Cervical Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 36
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways and combining it with chemotherapy may kill more tumor cells. Celecoxib may slow the growth of cervical cancer by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus celecoxib, fluorouracil, and cisplatin in treating patients who have locally advanced cervical cancer.
详细描述
OBJECTIVES:
- Determine treatment-related toxicity rates in patients with locally advanced cervical cancer treated with external beam radiotherapy and brachytherapy concurrently with celecoxib, fluorouracil, and cisplatin.
- Determine whether this regimen increases locoregional control rates, distant control, disease-free survival, and overall survival in these patients.
- Determine whether first-failure patterns in patients treated with this regimen are changed compared to historical controls.
OUTLINE: This is a multicenter study.
Patients undergo external beam pelvic radiotherapy once daily five days a weeks for 5 weeks beginning on day 1. Within 8 weeks, patients undergo low-dose or high-dose brachytherapy. Patients also receive concurrent chemotherapy comprising fluorouracil IV continuously over days 2-5, 23-26, and 44-47 and cisplatin IV over 4 hours on days 1, 22, and 43. Oral celecoxib is administered twice daily beginning on day 1 and continuing for 12 months.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
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
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous, adenocarcinoma, or adenosquamous carcinoma of the cervix
- •Stage IIB-IVA OR
- •Stage IB-IIA with pelvic node metastases and/or tumor size at least 5 cm
- •No small cell, carcinoid, glassy cell, clear cell, or adenoid cystic disease
- •No metastatic disease outside of pelvis
- •No para-aortic disease
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •AST or ALT no greater than 2.5 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 50 mL/min
- •Calcium no greater than 1.3 times ULN
- •Cardiovascular:
- •No severe heart disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •HIV negative
- •No prior allergy to sulfonamides or non-steroidal anti-inflammatory drugs (NSAIDs)
- •No prior hypersensitivity to celecoxib or any component of its formulation
- •No medical or psychiatric illness that would preclude study
- •No active gastrointestinal (GI) ulcer, GI bleeding, or inflammatory bowel disease
- •No other prior malignancy within the past 5 years except cutaneous basal cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No recent prior celecoxib or other cyclo-oxygenase-2 inhibitor
- •Chemotherapy:
- •No prior systemic chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to pelvis except transvaginal radiotherapy to control bleeding
- •No prior surgery for cervical cancer except biopsy
- •No concurrent phenytoin or lithium
- •No other concurrent NSAIDs
排除标准
- 未提供