Colo-rectal CancerPhase 2NCT03086538
Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy
A Phase 2 study testing Pemetrexed and Tarceva 100Mg Tablet in people with Colo-rectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is single center single arm prospective phase II study. In this study, efficacy and side effects of pemetrexed as salvage regimen on patients who failed all standard chemotherapy and total of 29 patients will be enrolled. Pemetrexed will be continued until disease progression is happened. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Pemetrexed and Tarceva 100Mg Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2017to 25 May 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced colorectal cancer failed from all standard chemotherapy
- History of refractoriness from chemotherapy including 5-FU, Oxaliplatin, Irinotecan
- Oral 5-FU agents are included standard chemotherapy
- Targeted agents such as cetuximab or bevacizumab are not included in inclusion criteria
- Patient must have willingness and ability to comply with the study protocol including visiting hospital for test and treatment during trial
- ECOG performance status 0~2
Show all 9Show fewer
- Measurable lesion (RECIST 1.1) must exist
- Expected survival should be more than 3 months from first dose of pemetrexed
- Adequate organ function as defined as below estimated 28 days before first doe of pemetrexed:
Who cannot join
- Poor performance status (ECOG PS ≥ 3)
- Patient can not take folic acid or Vitamin B12.
- History of previous treatment with pemetrexed
- History of malignant disease, except: non-melanoma skin cancer that properly treated, cured uterine cervical cancer or other solid tumor without evidence of recurrence within 5 years
- Patient can not swallow oral pills.
- Treatment with medication of clinical trial within 14 days (or longer duration according to specific agents)
Show all 10Show fewer
- Systemic chemotherapy or radiation (except palliative purpose) within 3 weeks (or longer duration according to specific agents)
- Toxicity from previous treatment as CTCAE grade > 1, except alopecia
- bowel obstruction or CTCAE grade 3/4 upper GI bleeding before 4 weeks
- QTc prolongation (QTc > 480msec) at resting is documented more than twice within 24 hours or family history of QT prolongation syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy: A Phase II Single Arm Prospective Study
This study is single center single arm prospective phase II study. In this study, efficacy and side effects of pemetrexed as salvage regimen on patients who failed all standard chemotherapy and total of 29 patients will be enrolled. Pemetrexed will be continued until disease progression is happened.
Read the detailed description
Antitumor effect of pemetrexed is already proven lung cancer, pleural mesothelioma, peritoneal mesothelioma and has been used as a standard therapeutic agent. In addition, this drug does not have severe side effects, pemetrexed is thought to be an important option for patients with poor performance status or elderly patients. Pemetrexed has been studied in colorectal cancer, Zhang et al have demonstrated that pemetrexed combined with gefitinib has a significantly synergistic effect on colorectal cancer cells (17). In two phase II studies in which patients received pemetrexed as first-line treatment for metastatic disease, objective response rates were 15 - 17 %. These trials were conducted prior to supplementation with folic acid and vitamin B12, which markedly decreased the frequency of hematologic toxicities of pemetrexed; routine supplementation is now included in all clinical trials of the agent (18).
Erlotinib (tarceva) is oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Erlotinib showed the effect in the maintanence therapy (combined with bevacizumab) in colorector cancer. Also, erolitinib had the effect in biliary tract cancer and pancreatic cancer. Our previous phase III trial for tarceva puls GEMOX (gemcitabine plus oxaliplatin) reported that adding to tarceva to GEMOX had more useful in the specific subgroup with EFGR overexpressed patients.
The aim of present study is to assess treatment efficacy and side effects of pemetrexed plus tarceva on EGFR overexpressed patients with refractory colorectal cancer and no treatment option whose performance status is relatively preserved.
<Pre-medication for Alimta> D-7 ~ Folic acid 1mg QD PO D-7 ~ Vitamin B12 1mg/9weeks IM D-1, D1, D2 Dexamethasone 4mg BID PO
<Treatment> D1 Alimta 500mg/m2 + NS 100ml IV infusion for 10mins Every 3weeks
- Conditions
- Colo-rectal Cancer
- Being tested
- Pemetrexed, Tarceva 100Mg Tablet
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Pemetrexed is a multitarget antifolate (MTA) whose mechanism of action relies mainly on the inhibition of TS, with weaker secondary effects on glycinamide ribonucleotide formyltransferase (GARFT) and dihydrofolate reductase (DHFR), leading to impairment of DNA synthesis and repair.
Tarceva 100Mg TabletDrug
Erlotinib (tarceva) is oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed+Tarceva | Experimental | Pemetrexed 500 mg/m2 IV Q 3 weeks Tarceva 100mg once daily, continous Receives: Drug: Pemetrexed; Drug: Tarceva 100Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start30 May 2017
- Primary completion30 Jan 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Model description
- Pemetrexed 500 mg/m2 IV Q 3 weeks Tarceva 100mg once daily, continous
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung tae Kim,PhMD, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086538
- Sponsor's protocol ID
- 2016-12-046
- Status last verified
- Jun 2022
- First submitted
- 16 Mar 2017
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim ST, Hong JY, Lee J, Park JO, Lim HY, Kang WK, Park YS. Pemetrexed/Erlotinib as a Salvage Treatment in Patients with High EGFR-Expressing Metastatic Colorectal Cancer Following Failure of Standard Chemotherapy: A Phase II Single-Arm Prospective Study. Target Oncol. 2020 Feb;15(1):67-73. doi: 10.1007/s11523-019-00691-z.
PubMed 31820199
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy: A Phase II Single Arm Prospective Study
- ClinicalTrials.gov ID
- NCT03086538
- Acronym / sponsor ID
- 2016-12-046
- Conditions
- Colo-rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 22 Mar 2017 (actual)
- 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.
This study is single center single arm prospective phase II study. In this study, efficacy and side effects of pemetrexed as salvage regimen on patients who failed all standard chemotherapy and total of 29 patients will be enrolled. Pemetrexed will be continued until disease progression is happened.
Detailed description
Antitumor effect of pemetrexed is already proven lung cancer, pleural mesothelioma, peritoneal mesothelioma and has been used as a standard therapeutic agent. In addition, this drug does not have severe side effects, pemetrexed is thought to be an important option for patients with poor performance status or elderly patients. Pemetrexed has been studied in colorectal cancer, Zhang et al have demonstrated that pemetrexed combined with gefitinib has a significantly synergistic effect on colorectal cancer cells (17). In two phase II studies in which patients received pemetrexed as first-line treatment for metastatic disease, objective response rates were 15 - 17 %. These trials were conducted prior to supplementation with folic acid and vitamin B12, which markedly decreased the frequency of hematologic toxicities of pemetrexed; routine supplementation is now included in all clinical trials of the agent (18).
Erlotinib (tarceva) is oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Erlotinib showed the effect in the maintanence therapy (combined with bevacizumab) in colorector cancer. Also, erolitinib had the effect in biliary tract cancer and pancreatic cancer. Our previous phase III trial for tarceva puls GEMOX (gemcitabine plus oxaliplatin) reported that adding to tarceva to GEMOX had more useful in the specific subgroup with EFGR overexpressed patients.
The aim of present study is to assess treatment efficacy and side effects of pemetrexed plus tarceva on EGFR overexpressed patients with refractory colorectal cancer and no treatment option whose performance status is relatively preserved.
<Pre-medication for Alimta> D-7 ~ Folic acid 1mg QD PO D-7 ~ Vitamin B12 1mg/9weeks IM D-1, D1, D2 Dexamethasone 4mg BID PO
<Treatment> D1 Alimta 500mg/m2 + NS 100ml IV infusion for 10mins Every 3weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pemetrexed 500 mg/m2 IV Q 3 weeks Tarceva 100mg once daily, continous
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed+Tarceva | Experimental | Drug: Pemetrexed, Drug: Tarceva 100Mg TabletPemetrexed 500 mg/m2 IV Q 3 weeks Tarceva 100mg once daily, continous |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced colorectal cancer failed from all standard chemotherapy
- Patient must have willingness and ability to comply with the study protocol including visiting hospital for test and treatment during trial
- ECOG performance status 0~2
- Measurable lesion (RECIST 1.1) must exist
- Expected survival should be more than 3 months from first dose of pemetrexed
Key exclusion criteria (10 listed)
- Poor performance status (ECOG PS ≥ 3)
- Patient can not take folic acid or Vitamin B12.
- History of previous treatment with pemetrexed
- History of malignant disease, except: non-melanoma skin cancer that properly treated, cured uterine cervical cancer or other solid tumor without evidence of recurrence within 5 years
- Patient can not swallow oral pills.
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 is a multitarget antifolate (MTA) whose mechanism of action relies mainly on the inhibition of TS, with weaker secondary effects on glycinamide ribonucleotide formyltransferase (GARFT) and dihydrofolate reductase (DHFR), leading to impairment of DNA synthesis and repair. | Drug | Pemetrexed+Tarceva |
| Tarceva 100Mg TabletErlotinib (tarceva) is oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). | Drug | Pemetrexed+Tarceva |
Primary outcome
Overall Response Rate
Time frame: 6 months
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 15 Jun 2022.
- Derived from this study: PubMed 31820199Kim ST, Hong JY, Lee J, Park JO, Lim HY, Kang WK, Park YS. Pemetrexed/Erlotinib as a Salvage Treatment in Patients with High EGFR-Expressing Metastatic Colorectal Cancer Following Failure of Standard Chemotherapy: A Phase II Single-Arm Prospective Study. Target Oncol. 2020 Feb;15(1):67-73. doi: 10.1007/s11523-019-00691-z.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tarceva 100Mg Tablet in people with Colo-rectal Cancer, run by Samsung Medical Center 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 9 inclusion and 10 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 15 Jun 2022. 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: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03086538, which also lists 1 linked publication.
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 15 Jun 2022.