NL-OMON40756招募中不适用
Phase I pharmacological study of continuous and intermittent chronomodulated capecitabine therapy - N14CCT
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 42 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histological or cytological proof of cancer
- •2. Patient who might benefit from treatment with capecitabine, e.g. colon, breast, pancreatic and gastric cancer, ACUP;
- •3. Age >= 18 years
- •4. WHO performance status of 0, 1 or 2;
- •5. Able and willing to give written informed consent
- •6. Able and willing to undergo blood sample collection during day-time and during the night for pharmacokinetic (PK) measurements and
- •pharmacodynamic (PD) analysis;
- •7. Life expectancy >= 3 months allowing adequate follow up;
- •8. Minimal acceptable safety laboratory values
- •a. ANC of >= 1.5 x 10^9 /L;
- •b. Platelet count of >= 100 x 10^9 /L;
- •c. Hemoglobin>= 6.5 mmol/L;
- •d. Hepatic function as defined by serum bilirubin <= 1.5 x ULN, ALAT and ASAT <= 3.0 x ULN (<=
- •5 x ULN in case of liver metastases);
- •e. Renal function as defined by serum creatinine <= 1.5 x ULN or creatinine clearance >= 60 ml/min (by Cockcroft-Gault formula).
- •9. No radio- or chemotherapy within 3 weeks of receiving first dose of study medication (palliative limited radiation for pain reduction is allowed);
- •10. Able and willing to swallow oral medication;
- •11. Negative pregnancy test (urine/serum) for female patients with childbearing potential.
排除标准
- •1. Dihydropyrimidine dehydrogenase (DPD) deficiency as assessed on the basis of DPYD IVS14+1G>A (DPYD*2A) and 2846A>T mutation analysis;
- •2. Women who are pregnant or breast feeding;
- •3. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive
- •methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms);
- •4. Bowel obstructions or motility disorders that may influence the absorption of drugs;
- •5. Pre-existing neuropathy > grade 1;
- •6. Unresolved (> grade 1) toxicities (except alopecia) of previous chemotherapy;
- •7. Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up;
- •8. The use of any drug or complementary alternative medicine that might interfere with the biotransformation of capecitabine and/or 5FU, like CYP2C9
- •substrates with narrow therapeutic windows (e.g., vitamin K antagonizing anticoagulants (acenocoumarol, phenprocoumon, warfarin), phenytoin),
- •allopurinol, folic acid, folinic acid, interferon alpha, metronidazol, sorivudine (and analogues).
- •Aluminium hydroxide and magnesium hydroxide can not be administered in the morning and evening/night: the use of aluminium hydroxide and
- •magnesium hydroxide is not an exclusion criterion when administered in the afternoon between 12:00 - 18:00 h;
- •9. Current participation or previous participation in a study with an investigational compound, or chemo- and/or radiotherapy within 21 days of
- •receiving first dose of study medication. (Palliative limited radiation for pain reduction is allowed);
- •10. Prior stem cell or bone marrow transplant;
- •11. Known hypersensitivity to the components of the study drug or its analogs;
- •12. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
- •13. Patients with a known history of hepatitis B or C;
- •14. Symptomatic cerebral or leptomeningeal metastases;
- •15. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of capecitabine according to this protocol or puts the patient at high risk for treatment-related
- •complications.
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