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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

Primary Purpose

Colorectal Cancer

Status

Active

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Pemetrexed

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is at least 20 years of age.
Written and voluntary informed consent understood, signed and dated.
They must have refractory or progressive colorectal cancer for which there is no further curative therapy available.
Subject able to adhere to the study visit schedule and other protocol requirements.
ECOG 0-2
At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits.
Must have a life expectancy of 3 months or more
Demonstrate adequate organ function
Negative urine or serum pregnancy test within 28 days of study treatment
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:

ECOG ≥ 3
History of malignancy in the last 5 years.
Subject has known historical or active infection with HIV, hepatitis B, or hepatitis C.
Breast-feeding or pregnant female
Patients can not the administration of Folic acid or Vitamin B12.
Before treatment with Pemetrexed.
Patients who can not swallow oral medication.
The most recent treatment with the clinical trial for the drug for 14 days prior to enrollment.
Systemic chemotherapy within three weeks after the administration of the last before the test treatment, radiation therapy patients who had been administered.
Except for the hair loss, it is induced before cancer treatment, all of toxicity in progress (> CTCAE1 grade).
Upper GI bleeding within registration before 4 weeks of Bowel obstruction or CTCAE3 or 4 grade.
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.

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pemetrexed

Arm Description

Pemetrexed 500 mg/m2 IV Q 3 weeks

Outcomes

Primary Outcome Measures

overall response rate

Secondary Outcome Measures

overall survival

progression free survival

Number of subjects with Adverse Events as a measure of safety and Tolerability

Full Information

NCT ID

NCT02588781

First Posted

October 27, 2015

Last Updated

June 13, 2022

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02588781

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 2015 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pemetrexed

Arm Type

Experimental

Arm Description

Pemetrexed 500 mg/m2 IV Q 3 weeks

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta

Intervention Description

Alimta 500mg/m2 + NS 100ml IV infusion for 10mins Every 3weeks

Primary Outcome Measure Information:

Title

overall response rate

Time Frame

2 years

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

2 years

Title

progression free survival

Time Frame

2 years

Title

Number of subjects with Adverse Events as a measure of safety and Tolerability

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is at least 20 years of age. Written and voluntary informed consent understood, signed and dated. They must have refractory or progressive colorectal cancer for which there is no further curative therapy available. Subject able to adhere to the study visit schedule and other protocol requirements. ECOG 0-2 At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits. Must have a life expectancy of 3 months or more Demonstrate adequate organ function Negative urine or serum pregnancy test within 28 days of study treatment 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: ECOG ≥ 3 History of malignancy in the last 5 years. Subject has known historical or active infection with HIV, hepatitis B, or hepatitis C. Breast-feeding or pregnant female Patients can not the administration of Folic acid or Vitamin B12. Before treatment with Pemetrexed. Patients who can not swallow oral medication. The most recent treatment with the clinical trial for the drug for 14 days prior to enrollment. Systemic chemotherapy within three weeks after the administration of the last before the test treatment, radiation therapy patients who had been administered. Except for the hair loss, it is induced before cancer treatment, all of toxicity in progress (> CTCAE1 grade). Upper GI bleeding within registration before 4 weeks of Bowel obstruction or CTCAE3 or 4 grade. 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.

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

State/Province

Seoul, Korea, Republic Of

ZIP/Postal Code

135-710

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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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