Gastric CancerPhase 2NCT02726399
Phase II Study of Ramucirumab With Chemotherapy in Patients With Metastatic Gastroesophageal Junction and Gastric Cancer
A Phase 2 study testing Ramucirumab, Trastuzumab and Capecitabine in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial summary
The purpose of this study is to compare any good and bad effects of using ramucirumab along with the usual trastuzumab and chemotherapy to using the usual chemotherapy and trastuzumab alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- Ramucirumab, Trastuzumab and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Mar 2016to 26 Feb 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have pathologically or cytologically MSKCC confirmed diagnosis of gastric or GEJ adenocarcinoma.
- Patients must have Stage IV gastric or GEJ adenocarcinoma with HER2 overexpression and/or amplification as determined by next generation sequencing assay, immunohistochemistry (IHC 3+) or fluorescent in situ hybridization (FISH+ is defined as HER2:CEP17 ratio ≥ 2.0). MSKCC confirmation of HER2 status is not mandatory prior to enrollment and treatment on study. For patients with outside HER2 testing, if sufficient tissue is available HER2 testing will be repeated at MSKCC for purpose of analysis and will not impact the patient's eligibility.
- Available archival tumor tissue should be submitted to MSKCC for IMPACT analysis, but will not be required prior to registration. Note: if tissue is depleted, patient will still be eligible after discussion with the PI.
- Patients must have disease that can be evaluated radiographically. This may be measurable disease or non-measurable disease per RECIST 1.1.
- Patients may have received no prior chemotherapy for Stage IV disease. Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration.
- Age of 18 years or older.
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- ECOG performance status 0-1.
- Peripheral neuropathy ≤ grade 1
- Patients who have adequate hepatic function as defined by a total bilirubin ≤1.5 times upper limit of institutional normal value (ULN) mg/dL (except patients with Gilbert's disease), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times ULN or ≤ 5.0 times the ULN in the setting of liver metastases.
- Patients who have adequate hematologic function, as evidenced by absolute neutrophil count (ANC) ≥1500/μL, hemoglobin ≥9 g/dL (5.58 mmol/L), and platelets ≥100,000/μL.
- Patients who have adequate renal function as defined by calculated creatinine clearance ≥60 mL/minute using the Cockcroft-Gaul formula or equivalent method.
- Patients whose urinary protein is ≤2+ on routine urinalysis (UA; if routine analysis is >2+, a 24-hour urine collection for protein must demonstrate <2g of protein in 24 hours to allow participation in this protocol).
- The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy). Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy.
- Patients, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods).
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of study entry.
Who cannot join
- Patients who have uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or >100 mmHg diastolic for >4 weeks) despite standard medical management.
- Patients receiving any concurrent anticancer therapy or investigational agents with the intention of treating gastric/GEJ cancer. Previously received trastuzumab as part of a regimen in the metastatic setting with evidence of progression. 89Zr-trastuzumab use as imaging agent for 89Zr-trastuzumab PET permitted.
- Patients having:
- Cirrhosis at a level of Child-Pugh B (or worse) or
- Cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.
- Active or clinically significant cardiac disease including:
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- Congestive heart failure - New York Heart Association (NYHA) > Class II.
- Active coronary artery disease.
- Left ventricular function <50%.
- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
- Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
- Patients who have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment.
- Patients who are receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-infalmmatory drugs (NSAIDs, inluding ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin (maximum dose 325 mg/day is permitted.
- Evidence or history of bleeding diathesis or coagulopathy.
- Patients who have experienced any Grade 3-4 GI bleeding within 3 months prior to enrolment.
- Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study.
- Patients with prior trastuzumab treatment.
- Patients with known active brain or central nervous system metastases, including leptomeningeal disease. Patients with treated and asymptomatic brain metastases may be eligible after discussion with PI.
- Patients who are pregnant or breast-feeding.
- Patients with a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment.
- The patient has undergone major surgery within 28 days prior to first dose of protocol therapy
- Patients may not have had major surgical procedure within 2 weeks of registration.
- Patients who have elective or planned major surgery to be performed during the course of the clinical trial.Minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy is permitted.
- Patients may not have had radiation within 28 days prior to first dose weeks of registration.
- Patients may not have any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center 1275 York Avenue
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
About this study
Official title: Phase II Study of Ramucirumab With Trastuzumab, Fluoropyrimidine, and Platinum in Patients With Metastatic HER2-Positive Gastroesophageal Junction and Gastric Cancer
The purpose of this study is to compare any good and bad effects of using ramucirumab along with the usual trastuzumab and chemotherapy to using the usual chemotherapy and trastuzumab alone.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Being tested
- Ramucirumab, Trastuzumab, Capecitabine, Cisplatin
- Keywords
- Ramucirumab, Trastuzumab, Capecitabine, Cisplatin, HER2-Positive, 15-301
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamucirumabDrug
Ramucirumab 8mg/kg administered intravenously on days 1 and 8 ever 21 days
TrastuzumabDrug
Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days
CapecitabineDrug
Capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period
CisplatinDrug
Cisplatin 80mg/m2 administered as an IV infusion every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Ramucirumab With Trastuzumab and Capecitabine/Cisplatin | Experimental | This will be a single arm study of ramucirumab 8mg/kg administered intravenously on days 1 and 8 + trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days. On subsequent cycles for all patients capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period, in addition to cisplatin 80mg/m2 administered as an IV infusion every 21 days. Each cycle consists of 21 days. Receives: Drug: Ramucirumab; Drug: Trastuzumab; Drug: Capecitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
as measured from the start of the ramucirumab and trastuzumab to the date of either documentation of disease progression on chemotherapy with trastuzumab and ramucirumab or death.
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 posted1 Apr 2016 (estimated)
- Study start18 Mar 2016
- Primary completion26 Feb 2019
- Study completion26 Feb 2019
Why it stopped: Low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yelena Janjigian, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726399
- Sponsor's protocol ID
- 15-301
- Status last verified
- Feb 2019
- First submitted
- 29 Mar 2016
- Last updated
- 21 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Ramucirumab With Trastuzumab, Fluoropyrimidine, and Platinum in Patients With Metastatic HER2-Positive Gastroesophageal Junction and Gastric Cancer
- ClinicalTrials.gov ID
- NCT02726399
- Acronym / sponsor ID
- 15-301
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Keywords
- Ramucirumab, Trastuzumab, Capecitabine, Cisplatin, HER2-Positive, 15-301
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual rate
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 18 Mar 2016 (actual)
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Posted 7 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare any good and bad effects of using ramucirumab along with the usual trastuzumab and chemotherapy to using the usual chemotherapy and trastuzumab alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramucirumab With Trastuzumab and Capecitabine/Cisplatin | Experimental | Drug: Ramucirumab, Drug: Trastuzumab, Drug: Capecitabine, Drug: CisplatinThis will be a single arm study of ramucirumab 8mg/kg administered intravenously on days 1 and 8 + trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days. On subsequent cycles for all patients capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period, in addition to cisplatin 80mg/m2 administered as an IV infusion every 21 days. Each cycle consists of 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have pathologically or cytologically MSKCC confirmed diagnosis of gastric or GEJ adenocarcinoma.
- Patients must have Stage IV gastric or GEJ adenocarcinoma with HER2 overexpression and/or amplification as determined by next generation sequencing assay, immunohistochemistry (IHC 3+) or fluorescent in situ hybridization (FISH+ is defined as HER2:CEP17 ratio ≥ 2.0). MSKCC confirmation of HER2 status is not mandatory prior to enrollment and treatment on study. For patients with outside HER2 testing, if sufficient tissue is available HER2 testing will be repeated at MSKCC for purpose of analysis and will not impact the patient's eligibility.
- Available archival tumor tissue should be submitted to MSKCC for IMPACT analysis, but will not be required prior to registration. Note: if tissue is depleted, patient will still be eligible after discussion with the PI.
- Patients must have disease that can be evaluated radiographically. This may be measurable disease or non-measurable disease per RECIST 1.1.
- Patients may have received no prior chemotherapy for Stage IV disease. Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration.
Key exclusion criteria (25 listed)
- Patients who have uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or >100 mmHg diastolic for >4 weeks) despite standard medical management.
- Patients receiving any concurrent anticancer therapy or investigational agents with the intention of treating gastric/GEJ cancer. Previously received trastuzumab as part of a regimen in the metastatic setting with evidence of progression. 89Zr-trastuzumab use as imaging agent for 89Zr-trastuzumab PET permitted.
- Patients having:
- Active or clinically significant cardiac disease including:
- Evidence or history of bleeding diathesis or coagulopathy.
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 |
|---|---|---|
| RamucirumabRamucirumab 8mg/kg administered intravenously on days 1 and 8 ever 21 days | Drug | Ramucirumab With Trastuzumab and Capecitabine/Cisplatin |
| TrastuzumabTrastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days | Drug | Ramucirumab With Trastuzumab and Capecitabine/Cisplatin |
| CapecitabineCapecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period | Drug | Ramucirumab With Trastuzumab and Capecitabine/Cisplatin |
| CisplatinCisplatin 80mg/m2 administered as an IV infusion every 21 days | Drug | Ramucirumab With Trastuzumab and Capecitabine/Cisplatin |
Primary outcome
Progression Free Survival
Time frame: 6 months
as measured from the start of the ramucirumab and trastuzumab to the date of either documentation of disease progression on chemotherapy with trastuzumab and ramucirumab or death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Yelena Janjigian, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ramucirumab, Trastuzumab and Capecitabine in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
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 15 inclusion and 25 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: stopped early, as of the sponsor's last update on 21 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 6 sites in United States. 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?
Yes. Results are posted in the registry (first posted 7 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (time frame: 6 months). 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 21 Jan 2020.