Pemetrexed plus tarceva as salvage treatment in EGFR overexpressed metastatic colorectal cancer patients who were failed after standard chemotherapy: A phase II single arm prospective study
- Conditions
- Neoplasms
- Registration Number
- KCT0003757
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 29
1. Provide full test subject consent prior to any testing procedure
2. adults over 20
3. Failure of standard anti-cancer treatment colon/job cancer.
- Failure of all 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 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 within 28 days, before day 1 treatment
Confirmation (in the case of fertile women)
10. Organized biopsy may be conducted if the disease is ongoing.
11. Preserved tissue or fresh tissue biopsy must be possible before treatment begins.
12 Patient showing EGFR overoccurrence on a tumor (By emmanohistocemistry (IHC) 2+ or 3+)
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 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 Grade 1) except hair loss.
9. Closing the unit within four weeks before registration or bleeding the upper GI of Class 3 or Grade 4 CTCAE.
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.
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. Person who corresponds to the prohibition of testing drugs
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Response Rate
- Secondary Outcome Measures
Name Time Method Overall Survival;Progression Free Survival;Safety profile