NCT00001431已完成1 期
A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.
详细描述
This is a Phase I trial of gemcitabine given weekly as a 30 minute infusion administered concurrently with radiation in patients with locally advanced or locally recurrent pancreatic carcinoma. Patients will be treated with external beam radiation therapy in a standard manner. Gemcitabine will be administered as a 30 minute infusion beginning on the first day of irradiation and weekly afterwards for a total of 5 doses. Patients will be assessed clinically for acute toxicity which will be graded per RTOG and DCT toxicity grading system.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.
- •Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon, Peripancreatic tissue, Adjacent large vessels, Stomach.
- •Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.
- •No lymphomas or neuroendocrine tumors.
- •No peritoneal carcinomatosis.
- •PRIOR/CONCURRENT THERAPY:
- •Biologic Therapy: More than 4 weeks since immunotherapy.
- •Chemotherapy:
- •No prior chemotherapy for newly diagnosed disease.
- •More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin).
- •Endocrine Therapy: More than 4 weeks since hormonal therapy.
- •Radiotherapy:
- •No prior radiotherapy for newly diagnosed disease.
- •No prior abdominal or pelvic radiotherapy.
- •More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for locally advanced disease after resection allowed.
- •Prior resection allowed.
- •Biliary decompression or gastric bypass allowed.
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over.
- •Performance status: ECOG 0-
- •Hematopoietic:
- •ANC greater than 2,000/mm(3).
- •Platelets greater than 100,000/mm(3).
- •Hepatic: AST/ALT no greater than 2.5 times normal.
- •Creatinine less than 1.5 mg/dL.
- •Creatinine clearance at least 60 mL/min,
- •Cardiovascular:
- •No myocardial infarction within 6 months.
- •No unstable angina.
- •No congestive heart failure (NYHA class III/IV).
- •HIV seronegative.
- •No medical or psychiatric contraindication to protocol therapy.
- •No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.
- •No pregnant or nursing women.
- •Adequate contraception required of fertile patients.
排除标准
- 未提供
研究者
研究点 (1)
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