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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

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Pemetrexed Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pemetrexed Alone as Salvage Treatment in Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy: A Phase II Single Arm Prospective Study
Actual Study Start Date : October 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pemetrexed
Pemetrexed 500 mg/m2 IV Q 3 weeks
Drug: Pemetrexed
Alimta 500mg/m2 + NS 100ml IV infusion for 10mins Every 3weeks
Other Name: Alimta




Primary Outcome Measures :
  1. overall response rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2 years ]
  2. progression free survival [ Time Frame: 2 years ]
  3. Number of subjects with Adverse Events as a measure of safety and Tolerability [ Time Frame: 2 years ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588781


Contacts
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Contact: Seungtae Kim, MD,Ph.D. 1087822153 ext 82 seungtae1.kim@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Seoul, Korea, Republic Of, Korea, Republic of, 135-710
Contact: yoonJeong Ahn    221487395 ext 82      
Principal Investigator: SeungTae Kim, M.D., Ph.D.         
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Seung tae Kim, MD,PhD,Division of hematology-oncology,Department of medicine, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02588781    
Other Study ID Numbers: 2015-05-071
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors