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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Pemetrexed

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic Of
    • Seoul, Seoul, Korea, Republic Of, Korea, Republic of, 135-710
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Alimta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall response rate	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	2 years
progression free survival	2 years
Number of subjects with Adverse Events as a measure of safety and Tolerability	2 years

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: 2015-05-071