None listed
Conditions
Interventions
Drug : Inject Pmetrexed 500 mg/m2 intravenous for 10 minutes every three weeks until disease progression.
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression Free Survival;Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactYoungsuk Park
Samsung Medical Center
Outcome results
None listed