A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of cycles received
研究概览
简要总结
This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis. 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. Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in patients with cervical carcinoma limited to the pelvis.
II. Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin and pelvic radiotherapy in these patients.
SECONDARY OBJECTIVES:
I. Determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary invasive carcinoma of the uterine cervix
- •Previously untreated disease
- •Any cell type
- •Stage IB_2, IIA, IIB, IIIA, IIIB, or IVA
- •Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is suspicious for adenopathy
- •No known metastases to scalene nodes or other organs outside the radiotherapy field
- •Study enrollment within 8 weeks of diagnosis
- •Performance status - GOG 0-2
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times normal
- •SGOT no greater than 3 times normal
- •Creatinine less than 2.0 mg/dL
- •No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiotherapy fields
- •No ureteral obstruction allowed unless treated with stent or nephrostomy tube
- •Not pregnant
- •Fertile patients must use effective contraception
- •No septicemia or severe infection
- •No circumstance that would preclude study completion or follow-up
- •No other malignancy within the past 5 years except nonmelanoma skin cancer
- •No prior cytotoxic chemotherapy
- •No prior pelvic or abdominal radiotherapy
- •No prior therapy for this malignancy
排除标准
- 未提供
研究组 & 干预措施
Treatment
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.
干预措施: Gemcitabine Hydrochloride (Drug)
Treatment
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.
干预措施: Cisplatin (Drug)
Treatment
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.
干预措施: Radiation Therapy (Radiation)
Treatment
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.
干预措施: Internal Radiation Therapy (Radiation)
结局指标
主要结局
Number of cycles received
时间窗: Up to 5 years
Dose of each drug
时间窗: Up to 5 years
Incidence of acute toxicity using the 21 major categories of the CTEP CTC version 2.0
时间窗: Up to 30 days after completion of radiation therapy
Incidence of chronic toxicity using the CTC RTOG/EORTC late radiation morbidity scoring scheme
时间窗: Up to 5 years
次要结局
- Site (local/distant) of treatment failure(Up to 5 years)
- Progression-free survival(Up to 5 years)
- Overall survival(Up to 5 years)