ISRCTN88098646已完成1 期
A pharmacokinetic study of adjuvant capecitabine in patients who have undergone proximal pancreatico-duodenectomy for resection of pancreatic adenocarcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Complete macroscopic resection for pathologically proven ductal adenocarcinoma (or poorly differentiated/undifferentiated carcinoma) of the pancreas (R0 or R1 resection)
- •2. Surgery must have included a proximal pancreatico-duodenectomy
- •3. Histological confirmation of the primary diagnosis and examination of all resection margins
- •4. At least 4 weeks since surgery, fully recovered from the operation and all surgical wounds fully healed
- •5. Aged greater than or equal to 18 years, either sex
- •6. World Health Organisation (WHO) performance status of less than or equal to 2
- •7. Haematological and biochemical indices (these measurements must be performed within one week prior to the patient being registered on the study):
- •7.1. Haemoglobin (Hb) greater than or equal to 9.0 g/dl (patients may be transfused to this level, however, Hb must be above 9.0 g/dl before registration)
- •7.2. Neutrophils greater than or equal to 1.5 x 10^9/l
- •7.3. Platelets (Plts) greater than or equal to 100 x 10^9/l
- •7.4. Serum bilirubin less than or equal to 1.5 x upper normal limit (ULN)
- •7.5. Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) less than or equal to 2.0 x ULN (if both are measured, both must be less than or equal to 2.0 x ULN)
- •7.6. Calculated creatinine clearance greater than or equal to 50 ml/min (uncorrected value) or isotope clearance measurement greater than or equal to 50 ml/min
- •8. Female patients of child-bearing potential must have a negative serum or urine pregnancy test within two weeks prior to enrolment and agree to use appropriate medically approved contraception for four weeks prior to entering the trial, during the trial, and for six months afterwards
- •9. Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards
- •10. Written, informed consent provided
- •11. Ability of the patient to co-operate with treatment and follow up must be ensured
- •12. Patients receiving oral anti-coagulation prior to entry into the study must be converted to low molecular weight heparin in light of the interaction between capecitabine and warfarin
排除标准
- •1. Patients with pancreatic lymphoma or other histological diagnosis
- •2. Macroscopically remaining tumour (R2 resection)
- •3. Evidence of malignant ascites, peritoneal or liver metastasis, or spread to other distant abdominal or extra-abdominal organs
- •4. History of confirmed ischaemic heart disease, concurrent congestive heart failure or prior history of class III/IV cardiac disease
- •5. Concurrent mechanical or malabsorptive disorders precluding affective oral administration of the drug (excluding malabsorption related directly to proximal pancreatic-duodenectomy)
- •6. Pregnancy or lactation
- •7. Patients known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •8. Patients who are high medical risks because of non-malignant systemic disease including active uncontrolled infection
- •9. Any other serious medical or psychological condition precluding adjuvant treatment
- •10. Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial
研究者
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