Gastric CancerPhase 2NCT01953419
Phase II Study of Pemetrexed in Advanced or Recurrent Gastric Cancer After Chemotherapy
A Phase 2 study testing Pemetrexed disodium in people with Gastric Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Pemetrexed disodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Jun 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histological confirmed inoperable or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
- age between 18 and 80 years
- ECOG performance status of 0 to 2
- life expectancy ≥ 12 weeks
- has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
- at least one prior chemotherapy regimen
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- adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3
- platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL
- adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min,
- adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN.
Who cannot join
- other primary malignancy
- symptomatic central nervous system metastasis
- pregnancy or lactation
- cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure
- ongoing infection
- inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs for 2 days before and after pemetrexed administration unwillingness to take folic acid or vitamin B12 supplementation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pemetrexed for Previously Treated Patients With Metastatic Gastric Cancer: a Prospective Phase II Study
This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer.
Read the detailed description
Patients enrolled in this study received pemetrexed 500mg/m2, once every 21 days, until the presence of progressive disease or unacceptable toxicity. All patients took dexamethasone 3.75 mg twice daily, starting from the day before and continuing to the day after the drug administration. Patients were instructed to take oral folic acid 400 mg daily beginning 5 days before the first therapy and until the final therapy.Patients received Vitamin B12 very 3 cycle of chemoherapy. Granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) or Erythropoietin (EPO) was not allowed, but they could be used when the patients suffered from bone marrow depression.
- Conditions
- Gastric Cancer
- Being tested
- Pemetrexed disodium
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemetrexed disodiumDrug
Also called LY-231514, brand name: Alimta
Patients received Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.Patients were instructed to take oral folic acid 400 mg daily beginning 5 days before the first therapy and until the final therapy. Patients received vitamin B12 before the first cycle of Pemetrexed and every three cycles of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | received Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity Receives: Drug: Pemetrexed disodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startSep 2010
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruihua Xu, Sun Yat-sen University
- Investigators
- RH Xu, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953419
- Sponsor's protocol ID
- PEM001
- Status last verified
- Jul 2016
- First submitted
- 12 Aug 2013
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pemetrexed for Previously Treated Patients With Metastatic Gastric Cancer: a Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT01953419
- Acronym / sponsor ID
- PEM001
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Oct 2013 (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.
This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer.
Detailed description
Patients enrolled in this study received pemetrexed 500mg/m2, once every 21 days, until the presence of progressive disease or unacceptable toxicity. All patients took dexamethasone 3.75 mg twice daily, starting from the day before and continuing to the day after the drug administration. Patients were instructed to take oral folic acid 400 mg daily beginning 5 days before the first therapy and until the final therapy.Patients received Vitamin B12 very 3 cycle of chemoherapy. Granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) or Erythropoietin (EPO) was not allowed, but they could be used when the patients suffered from bone marrow depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Pemetrexed disodiumreceived Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histological confirmed inoperable or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
- age between 18 and 80 years
- ECOG performance status of 0 to 2
- life expectancy ≥ 12 weeks
- has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
Key exclusion criteria (6 listed)
- other primary malignancy
- symptomatic central nervous system metastasis
- pregnancy or lactation
- cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure
- ongoing infection
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 |
|---|---|---|
| Pemetrexed disodiumAlso: LY-231514, brand name: AlimtaPatients received Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.Patients were instructed to take oral folic acid 400 mg daily beginning 5 days before the first therapy and until the final therapy. Patients received vitamin B12 before the first cycle of Pemetrexed and every three cycles of chemotherapy. | Drug | Treatment group |
Primary outcome
ORR
Time frame: 6 weeks
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 28 Jul 2016.
- Individual participant dataSharing planned: No
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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.
RH Xu principal investigator
Sun Yat-Sen University Cancer Center
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 disodium in people with Gastric Cancer, run by Sun Yat-sen University at 1 site in China.
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 10 inclusion and 6 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 28 Jul 2016. 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 China. 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?
ORR (time frame: 6 weeks). 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 28 Jul 2016.