Metastatic Colorectal CancerPhase 2NCT02723578
Pemetrexed and Erlotinib for Metastatic Colorectal Cancer
A Phase 2 study testing Pemetrexed and Erlotinib in people with Metastatic Colorectal Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Pemetrexed is a multitargeted antifolate, which primarily inhibits thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase in the folate-dependent metabolic process. Nowadays, pemetrexed is used to treat malignant pleural mesothelioma and non-squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Pemetrexed and Erlotinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2015to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥ 19 years
- Histologic or cytologic confirmed diagnosis of colorectal carcinoma with metastatic (STAGE IV) disease.
- Confirmed KRAS(codon 12 or 13) status
- Prior chemotherapy for metastatic disease is required; prior regimens must include fluoropyrimidine, oxaliplatin and irinotecan
- Eastern Cooperative Oncology Group performance status ≤ 2
- Patients who can swallow oral medication.
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- Life expectancy of greater than 3 months
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count ≥ 1,500/mm3
- hemoglobin ≥ 9 g/dl
- platelets ≥ 100,000/mm3
- serum total bilirubin ≤ 1.5 X institutional upper limit of normal
- aspartate aminotransferase(SGOT)/alanine aminotransferase(SGPT) ≤ 3.0 X institutional upper limit of normal (≤ 5 times the upper institutional limits of normal if hepatic metastases are present)
- serum creatinine ≤ 1.5 times the institutional upper limits of normal or Creatinine Clearance ≥ 50ml/min
- The effects of Pemetrexed and Erlotinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because therapeutic agents used in this trial are known to be teratogenic, female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception (hormonal or barrier method of birth control; abstinence) during the study and for 6 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Participant is willing and able to give informed consent for participation in the study. Voluntary signed and dated written informed consent form in accordance with regulatory and institutional guidelines obtained before the performance of any protocol-related procedures not part of normal patient care.
Who cannot join
- Previous treatment with Pemetrexed and Erlotinib
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pemetrexed or Erlotinib or other agents used in the study
- Patients who can not allow the administration of Folic acid or Vitamin B12.
- Past or current history of neoplasm other than colorectal carcinoma with a disease-free interval of less than 5 years, except for non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix.
- Systemic chemotherapy within three weeks after the administration of the last before the test treatment
- Major surgical operation or major trauma within 4 weeks.
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- Patients who have had wide-ranged radiotherapy within 4 weeks or limited radiotherapy within 2 2 weeks.
- Persistent toxicity (> CTCAE grade 1) related to previous treatment except for the hair loss.
- Patients with active brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Breast-feeding or pregnant female
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul, 03722
About this study
Official title: A Phase 2 Study of Pemetrexed and Erlotinib for Metastatic Colorectal Cancer Refractory to Standard Chemotherapy
Pemetrexed is a multitargeted antifolate, which primarily inhibits thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase in the folate-dependent metabolic process. Nowadays, pemetrexed is used to treat malignant pleural mesothelioma and non-squamous non-small cell lung cancer. Preclinical and clinical studies showed that pemetrexed had cytotoxic activity in many kinds of cancers including colorectal cancer. Erlotinib is a tyrosine-kinase inhibitor of EGFR, which was approved for the treatment of non-small cell lung cancer. Erlotinib also showed activity to colorectal cancer cells. Recently, Zhang et al. demonstrated synergistic cytotoxicity of pemetrexed and gefitinib in preclinical study.
In this multicenter, non randomized, open label phase II study, investigators aimed to evaluate the efficacy and safety of Pemetrexed and Erlotinib combination.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Pemetrexed, Erlotinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Pemetrexed 500 mg/m2 IV over 10 minutes on day 1 every 21 days
ErlotinibDrug
Erlotinib 150 mg PO once daily on days 1-21 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed and Erlotinib | Experimental | Pemetrexed 500 mg/m2 IV over 10 minutes on day 1 every 21 days and Erlotinib 150 mg PO once daily on days 1-21 every 21 days Receives: Drug: Pemetrexed; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: up to 2 years
Progression-free survival
Measured: up to 2 years
Secondary outcomes (3)
Overall survival
Measured: up to 2 years
Disease control rate
Measured: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start1 Dec 2015
- Primary completionAug 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joong Bae Ahn, Yonsei University
- Investigators
- Joong Bae Ahn, Principal investigator, Yonsei Cancer Center, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723578
- Sponsor's protocol ID
- 4-2015-0617
- Status last verified
- Jan 2020
- First submitted
- 9 Mar 2016
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Pemetrexed and Erlotinib for Metastatic Colorectal Cancer Refractory to Standard Chemotherapy
- ClinicalTrials.gov ID
- NCT02723578
- Acronym / sponsor ID
- 4-2015-0617
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pemetrexed is a multitargeted antifolate, which primarily inhibits thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase in the folate-dependent metabolic process. Nowadays, pemetrexed is used to treat malignant pleural mesothelioma and non-squamous non-small cell lung cancer. Preclinical and clinical studies showed that pemetrexed had cytotoxic activity in many kinds of cancers including colorectal cancer. Erlotinib is a tyrosine-kinase inhibitor of EGFR, which was approved for the treatment of non-small cell lung cancer. Erlotinib also showed activity to colorectal cancer cells. Recently, Zhang et al. demonstrated synergistic cytotoxicity of pemetrexed and gefitinib in preclinical study.
In this multicenter, non randomized, open label phase II study, investigators aimed to evaluate the efficacy and safety of Pemetrexed and Erlotinib combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed and Erlotinib | Experimental | Drug: Pemetrexed, Drug: ErlotinibPemetrexed 500 mg/m2 IV over 10 minutes on day 1 every 21 days and Erlotinib 150 mg PO once daily on days 1-21 every 21 days |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female, aged ≥ 19 years
- Histologic or cytologic confirmed diagnosis of colorectal carcinoma with metastatic (STAGE IV) disease.
- Confirmed KRAS(codon 12 or 13) status
- Prior chemotherapy for metastatic disease is required; prior regimens must include fluoropyrimidine, oxaliplatin and irinotecan
- Eastern Cooperative Oncology Group performance status ≤ 2
Key exclusion criteria (11 listed)
- Previous treatment with Pemetrexed and Erlotinib
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pemetrexed or Erlotinib or other agents used in the study
- Patients who can not allow the administration of Folic acid or Vitamin B12.
- Past or current history of neoplasm other than colorectal carcinoma with a disease-free interval of less than 5 years, except for non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix.
- Systemic chemotherapy within three weeks after the administration of the last before the test treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedPemetrexed 500 mg/m2 IV over 10 minutes on day 1 every 21 days | Drug | Pemetrexed and Erlotinib |
| ErlotinibErlotinib 150 mg PO once daily on days 1-21 every 21 days | Drug | Pemetrexed and Erlotinib |
Primary outcome
Overall response rate
Time frame: up to 2 years
Progression-free survival
Time frame: up to 2 years
3 secondary outcomes
Overall survival
Time frame: up to 2 years
Disease control rate
Time frame: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joong Bae Ahn principal investigator
Yonsei Cancer Center, Yonsei University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed and Erlotinib in people with Metastatic Colorectal Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.