Gastric CancerPhase 2EXTRANCT00477711
A Study of Cetuximab(Erbitux) With Cisplatin and Capecitabine(Xeloda)as 1st Line Treatment in the Advanced Gastric Cancer
A Phase 2 study testing cetuximab, cisplatin, capecitabine in people with Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
The purpose of this study is to investigate whether cetuximab (Erbitux®) with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- cetuximab, cisplatin, 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
- 41 participants
- Where
- 1 siteChina
- Study dates
- Mar 2007to Feb 2009
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having signed informed consent
- Age 18 to 75 years old
- Histologically confirmed gastric adenocarcinoma
- Unresectable recurrent or metastatic disease
- Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 12 months
- Measurable disease according to the RECIST criteria
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- Karnofsky performance status ≥60
- Life expectancy of ≥2 month
- No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
- ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
- Serum albumin level ≥3.0g/dL
- Serum AKP < 2.5 times ULN
- Serum creatinine <1.5mg/dL
- Bilirubin level < 1.5mg/dL
- Serum creatinine <1.5 times ULN
- WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl
Who cannot join
- Brain metastasis (known or suspected)
- Previous systemic therapy for metastatic gastric cancer
- Inability to take oral medication
- Previous EGFR pathway-targeting therapy
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
- Heart failure, coronary artery disease, myocardial infarction within the last 6 months
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- Known allergy to any study treatment
- Pregnancy or lactation period
- Any investigational agent within the past 28 days
- Other previous malignancy within 5 year, except non-melanoma skin cancer
- Previous adjuvant therapy with capecitabine+platinum
- Pre-existing neuropathy>grade 1
- Legal incapacity
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University,School of Oncology, Gastrointestinal Department
Beijing, 100036
About this study
The purpose of this study is to investigate whether cetuximab (Erbitux®) with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective.
Read the detailed description
Gastric cancer remains one of the major causes of cancer deaths around the world, especially in Asia. Previous study of ML17032 has proved that XP(capecitabine plus cisplatin)is effective in advanced gastric cancer, with the overall response rate of 41%, the median PFS of 5.6 month. Recently, the EGFR monoclonal antibody of cetuximab has shown to be successful in treating advanced colorectal cancer with or without chemotherapy. Since EGFR also express in gastric cancer, A single arm, open, multicenter phase II study of cetuximab in combination with cisplatin and capecitabine as first line treatment in patient with advanced gastric cancer.If applicable, the value of mutations in k-ras, b-raf, P53, and EGFR copy number to predict the clinical response to cetuximab in advanced gastric cancer patients will also be accessed.Tumor tissue from study patients will be checked for k-ras, b-raf, and P53 mutation by sequencing and for EGFR copy number by chromogenic in situ hybridization. DNA will be extracted from paraffin-embedded samples.
- Conditions
- Gastric Cancer
- Being tested
- cetuximab, cisplatin, capecitabine
- Keywords
- Cetuximab, cisplatin, capecitabine, first line treatment
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximab, cisplatin, capecitabineDrug
Product 1: Cetuximab(Erbitux®) Dosing schedule: 400mg/m2 initial dose and then 250mg/m2 ,weekly dose Mode of administration: intravenously Product 2: capecitabine Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks Mode of administration: orally Product 3: cisplatin Dosing schedule: 80mg/m2, day 1 of every 3 weeks Mode of administration: intravenously
| Study group | Role | What they receive |
|---|---|---|
| C225+Chemotherapy | Experimental | Not described Receives: Drug: cetuximab, cisplatin, capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate
Measured: 1 year
Secondary outcomes (1)
Time to progression Disease control rate Overall survival K-ras, b-raf, p53 gene mutation and EGFR gene copy number vs. tumor response safety
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionFeb 2009
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 Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, MD, Principal investigator, Peking University, School of oncology, Gastrointestinal Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477711
- Sponsor's protocol ID
- EMR 62202-769
- Acronym
- EXTRA
- Status last verified
- May 2015
- First submitted
- 22 May 2007
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang X, Xu J, Liu H, Yang L, Liang J, Xu N, Bai Y, Wang J, Shen L. Predictive biomarkers for the efficacy of cetuximab combined with cisplatin and capecitabine in advanced gastric or esophagogastric junction adenocarcinoma: a prospective multicenter phase 2 trial. Med Oncol. 2014 Oct;31(10):226. doi: 10.1007/s12032-014-0226-y. Epub 2014 Sep 19.
PubMed 25234930
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Cetuximab(Erbitux) With Cisplatin and Capecitabine(Xeloda)as 1st Line Treatment in the Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00477711
- Acronym / sponsor ID
- EXTRA / EMR 62202-769
- Conditions
- Gastric Cancer
- Keywords
- Cetuximab, cisplatin, capecitabine, first line treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 May 2007 (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.
The purpose of this study is to investigate whether cetuximab (Erbitux®) with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective.
Detailed description
Gastric cancer remains one of the major causes of cancer deaths around the world, especially in Asia. Previous study of ML17032 has proved that XP(capecitabine plus cisplatin)is effective in advanced gastric cancer, with the overall response rate of 41%, the median PFS of 5.6 month. Recently, the EGFR monoclonal antibody of cetuximab has shown to be successful in treating advanced colorectal cancer with or without chemotherapy. Since EGFR also express in gastric cancer, A single arm, open, multicenter phase II study of cetuximab in combination with cisplatin and capecitabine as first line treatment in patient with advanced gastric cancer.If applicable, the value of mutations in k-ras, b-raf, P53, and EGFR copy number to predict the clinical response to cetuximab in advanced gastric cancer patients will also be accessed.Tumor tissue from study patients will be checked for k-ras, b-raf, and P53 mutation by sequencing and for EGFR copy number by chromogenic in situ hybridization. DNA will be extracted from paraffin-embedded samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C225+Chemotherapy | Experimental | Drug: cetuximab, cisplatin, capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Having signed informed consent
- Age 18 to 75 years old
- Histologically confirmed gastric adenocarcinoma
- Unresectable recurrent or metastatic disease
- Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 12 months
Key exclusion criteria (13 listed)
- Brain metastasis (known or suspected)
- Previous systemic therapy for metastatic gastric cancer
- Inability to take oral medication
- Previous EGFR pathway-targeting therapy
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
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 |
|---|---|---|
| cetuximab, cisplatin, capecitabineProduct 1: Cetuximab(Erbitux®) Dosing schedule: 400mg/m2 initial dose and then 250mg/m2 ,weekly dose Mode of administration: intravenously Product 2: capecitabine Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks Mode of administration: orally Product 3: cisplatin Dosing schedule: 80mg/m2, day 1 of every 3 weeks Mode of administration: intravenously | Drug | C225+Chemotherapy |
Primary outcome
Tumor response rate
Time frame: 1 year
1 secondary outcome
Time to progression Disease control rate Overall survival K-ras, b-raf, p53 gene mutation and EGFR gene copy number vs. tumor response safety
Time frame: 5 year
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 19 May 2015.
- Derived from this study: PubMed 25234930Zhang X, Xu J, Liu H, Yang L, Liang J, Xu N, Bai Y, Wang J, Shen L. Predictive biomarkers for the efficacy of cetuximab combined with cisplatin and capecitabine in advanced gastric or esophagogastric junction adenocarcinoma: a prospective multicenter phase 2 trial. Med Oncol. 2014 Oct;31(10):226. doi: 10.1007/s12032-014-0226-y. Epub 2014 Sep 19.
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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.
Lin Shen, MD principal investigator
Peking University, School of oncology, Gastrointestinal Department
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 cetuximab, cisplatin, capecitabine in people with Gastric Cancer, run by Peking 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 16 inclusion and 13 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 19 May 2015. 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?
Tumor response rate (time frame: 1 year). 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 NCT00477711, 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 19 May 2015.