Gastric CancerPhase 2STAGENCT00699881
Study of Cetuximab to Treat Gastric Cancer
A Phase 2 study testing cetuximab in people with Gastric Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- ECOG performance scale ≤ 1
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- Adequate hepatic, renal, heart, and hematologic functions (platelets>80 × 109/L, neutrophil>2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)
Who cannot join
- Pregnant or lactating women
- Concurrent cancer
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Neuropathy, brain, or leptomeningeal involvement
- Uncontrolled significant comorbid conditions and previous radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Cetuximab (Erbitux®) in Combination With Modified FOLFIRI in Patients With Advanced Gastric Cancer Who Failed to First-line Chemotherapy
The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy
Read the detailed description
Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of cetuximab combined with FOLFIRI in metastatic colorectal cancer, we design this clinical trial to evaluate the efficacy and safety of cetuximab combined with FOLFIRI for A/MGC patients as a second line treatment.
- Conditions
- Gastric Cancer
- Being tested
- cetuximab
- Keywords
- Time to Progression, Toxicity, Overall survival, Response rate, Quality of live
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabDrug
Also called treatment group
cetuximab 400mg/m2 as initial dose, subsequently at 250mg/m2 weekly dose. CPT-11 180 mg/m2 CF 200 mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | administer cetuximab in combination with modified FOLFIRI Receives: Drug: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to progression
Measured: every 8 weeks
Secondary outcomes (1)
toxicity
Measured: every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2009
- Study completionOct 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 Fudan 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Jin Li, PhD, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699881
- Sponsor's protocol ID
- EMR 62202- 806
- Acronym
- STAGE
- Status last verified
- Jun 2008
- First submitted
- 17 Jun 2008
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu X, Guo W, Zhang W, Yin J, Zhang J, Zhu X, Liu T, Chen Z, Wang B, Chang J, Lv F, Hong X, Wang H, Wang J, Zhao X, Wu X, Li J. A multi-center phase II study and biomarker analysis of combined cetuximab and modified FOLFIRI as second-line treatment in patients with metastatic gastric cancer. BMC Cancer. 2017 Mar 14;17(1):188. doi: 10.1186/s12885-017-3174-z.
PubMed 28288572
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Cetuximab (Erbitux®) in Combination With Modified FOLFIRI in Patients With Advanced Gastric Cancer Who Failed to First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT00699881
- Acronym / sponsor ID
- STAGE / EMR 62202- 806
- Conditions
- Gastric Cancer
- Keywords
- Time to Progression, Toxicity, Overall survival, Response rate, Quality of live
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Jun 2008 (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 evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy
Detailed description
Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of cetuximab combined with FOLFIRI in metastatic colorectal cancer, we design this clinical trial to evaluate the efficacy and safety of cetuximab combined with FOLFIRI for A/MGC patients as a second line treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: cetuximabadminister cetuximab in combination with modified FOLFIRI |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- ECOG performance scale ≤ 1
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- Adequate hepatic, renal, heart, and hematologic functions (platelets>80 × 109/L, neutrophil>2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Concurrent cancer
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Neuropathy, brain, or leptomeningeal involvement
- Uncontrolled significant comorbid conditions and previous radiotherapy
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 |
|---|---|---|
| cetuximabAlso: treatment groupcetuximab 400mg/m2 as initial dose, subsequently at 250mg/m2 weekly dose. CPT-11 180 mg/m2 CF 200 mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle | Drug | A |
Primary outcome
time to progression
Time frame: every 8 weeks
1 secondary outcome
toxicity
Time frame: every 8 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 23 Dec 2009.
- Derived from this study: PubMed 28288572Liu X, Guo W, Zhang W, Yin J, Zhang J, Zhu X, Liu T, Chen Z, Wang B, Chang J, Lv F, Hong X, Wang H, Wang J, Zhao X, Wu X, Li J. A multi-center phase II study and biomarker analysis of combined cetuximab and modified FOLFIRI as second-line treatment in patients with metastatic gastric cancer. BMC Cancer. 2017 Mar 14;17(1):188. doi: 10.1186/s12885-017-3174-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.
Jin Li, PhD, M.D. principal investigator
Fudan University
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 in people with Gastric Cancer, run by Fudan 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 4 inclusion and 5 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 23 Dec 2009. 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?
time to progression (time frame: every 8 weeks). 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 NCT00699881, 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 23 Dec 2009.