KCT0003517进行中（未招募）未知
Pemetrexed alone as salvage treatment in metastatic colorectal cancer patients who were failed after standard chemotherapy: A phase II single arm prospective study
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Provide subject consent prior to any study procedure
- •2. adults over 20
- •3. Failure of standard anti-cancer treatment colon/rectal cancer.
- •- Failure of anti-cancer drugs in FU, Oxaliplatin and Irinotecan.
- •- Oral type FU sanctions are also included in standard treatment.
- •- The use of targeted medications such as Cetuximab or Bevacizumab is not included in the selection criteria.
- •4. Patients must have the will and ability to comply with the clinical trial plan during the test period, including treatment and scheduled visits and examinations.
- •5. ECOG performance status from 0 to 2.
- •6. Have measurable lesions (RECIST(Response evaluation criteria in solid tumors) 1.1)
- •7. The patient's life expectancy should be at least three months from the date of the first dose proposed.
- •8. Patients should have acceptable bone marrow, liver, and kidney test results measured within 28 days prior to testing treatment administration as specified below:
- •- Hemoglobin = 9.0 g/L (allow blood transfusion)
- •- Absolute number of hojunggu (ANC) = 1.5 x 109/L
- •- White blood cells (WBC) > 3 x 109/L
- •- Number of platelets = 100 x 109/L (allow blood transfusion)
- •- Total Bilirubin = 1.5 x ULN (not including Glibert's noise base)
- •- AST (SGOT)/ALT (SGPT) = 2.5 x Normal upper limit of test organization. But, uh, there's a liver transfer.
- •Excludes if it should be = 5x ULN
- •- serum creatine ??? 1.5 x ULN of testing agency
- •9. Urine or serum pregnancy test voice should be negative within 28 days of test treatment, and must be confirmed before day 1 treatment (for fertile women).
- •10. Biopsy may be conducted in case of disease progresstion.
- •11. Preserved tissue or fresh tissue biopsy must be possible before treatment begins.
排除标准
- •1. Patients with poor general health (patients with ECOG PS 3 or more).
- •2. Patients who are unable to administer Folic acid or Vitamin B12.
- •3. Previous treatment using Pemetrexed.
- •4. Patient with second primary cancer, exception: appropriately treated non-black skin cancer, fully cured
- •Cervical cervical cervical cancer or other solid tumors that have been completely cured without proof of disease within five years.
- •5. Patients who cannot swallow oral medication.
- •6. Treatment using clinical trial medications for the last 14 days before registration (or longer periods depending on the prescribed characteristics of the medications used).
- •7. Patients who were given full-body chemotherapy, radiation therapy (excluding mitigating purposes), within three weeks after the last dose (or longer periods depending on the prescribed characteristics of the drug used).
- •8. All toxicity induced by previous cancer treatments (> CTCAE(Common Terminology Criteria for Adverse Events) Grade 1) except alopecia.
- •9. Ileus or bleeding the upper GI of Class 3 or Grade 4 CTCAE(Common Terminology Criteria for Adverse Events) within 4 weeks before enrollment.
- •10. A QTcB that can be measured from the ECG at break time more than once within 24 hours is > 480msec, or has a family history of QT extended syndrome.
- •11. Patients with heart problems such as: Uncontrolled hypertension (medical treatment)
- •BP = 150/95 mmHg), left ventricle emission coefficient measured by cardiac ultrasonography < 55%;
- •At rest, the heart rate on the ECG is > 100 bpm at ventricular fibrillation, symptom heart failure (NYHA II - IV grade), heart disease of previous or present heart disease, severe valve syndrome,
- •12. Female patients who are breastfeeding or leasing. In case a patient of a male or female who is reproducible does not use effective contraception.
- •12. Female patients who are breastfeeding or leasing. In case a patient of a male or female who is reproducible does not use effective contraception.
- •13. There are grounds for severe or unregulated whole-body diseases, active infections, active bleeding, or kidney transplants, including patients known as hepatitis B, hepatitis C or HIV (HIV).
- •14. If any of the notices given in the notice box are prohibited (a patient suffering from anaphylaxis against this drug or an accessory ingredient, inoculation of yellow fever vaccine)
研究者
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