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Pemetrexed Alone as Salvage Treatment in Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy: A Phase II Single Arm Prospective Study

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ClinicalTrials.gov Identifier: NCT02588781
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Seung tae Kim, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE October 27, 2015
First Posted Date  ICMJE October 28, 2015
Last Update Posted Date December 30, 2019
Actual Study Start Date  ICMJE October 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
overall response rate [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
  • overall survival [ Time Frame: 2 years ]
  • progression free survival [ Time Frame: 2 years ]
  • Number of subjects with Adverse Events as a measure of safety and Tolerability [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pemetrexed Alone as Salvage Treatment in Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy: A Phase II Single Arm Prospective Study
Official Title  ICMJE Pemetrexed Alone as Salvage Treatment in Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy: A Phase II Single Arm Prospective Study
Brief Summary

Pemetrexed is an anticancer agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication. In vitro studies have shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides.Pemetrexed is used as a standard therapeutic agent for lung cancer, pleural mesothelioma, peritoneal mesothelioma.In addition to these effective anti-cancer effect, Pemetrexed is not severe side effects of the medicine.

Pemetrexed has been research in colon cancer. Zhang, etc., demonstrated the anti-cancer effect of Pemetrexed in human colon cancer Cells.

Although sometimes made also two or more clinical studies, Pemetrexed was reported 15-17% of the treatment response rate in these two studies.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: Pemetrexed
Alimta 500mg/m2 + NS 100ml IV infusion for 10mins Every 3weeks
Other Name: Alimta
Study Arms  ICMJE Experimental: Pemetrexed
Pemetrexed 500 mg/m2 IV Q 3 weeks
Intervention: Drug: Pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2015)
29
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is at least 20 years of age.
  2. Written and voluntary informed consent understood, signed and dated.
  3. They must have refractory or progressive colorectal cancer for which there is no further curative therapy available.
  4. Subject able to adhere to the study visit schedule and other protocol requirements.
  5. ECOG 0-2
  6. At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits.
  7. Must have a life expectancy of 3 months or more
  8. Demonstrate adequate organ function
  9. Negative urine or serum pregnancy test within 28 days of study treatment
  10. Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status.

Exclusion Criteria:

  1. ECOG ≥ 3
  2. History of malignancy in the last 5 years.
  3. Subject has known historical or active infection with HIV, hepatitis B, or hepatitis C.
  4. Breast-feeding or pregnant female
  5. Patients can not the administration of Folic acid or Vitamin B12.
  6. Before treatment with Pemetrexed.
  7. Patients who can not swallow oral medication.
  8. The most recent treatment with the clinical trial for the drug for 14 days prior to enrollment.
  9. Systemic chemotherapy within three weeks after the administration of the last before the test treatment, radiation therapy patients who had been administered.
  10. Except for the hair loss, it is induced before cancer treatment, all of toxicity in progress (> CTCAE1 grade).
  11. Upper GI bleeding within registration before 4 weeks of Bowel obstruction or CTCAE3 or 4 grade.
  12. Subject who experienced a recent myocardial infarction, including severe/unstable angina pectoris, coronary/peripheral artery bypass graft, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, significant or uncontrolled cardiovascular disease CHF, and cerebrovascular accident or transient ischemic attack, or seizure disorder in the past year.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seungtae Kim, MD,Ph.D. 1087822153 ext 82 seungtae1.kim@samsung.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02588781
Other Study ID Numbers  ICMJE 2015-05-071
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seung tae Kim, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP