Esophageal CancerPhase 2NCT00439608
Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer
A Phase 2 study testing Cetuximab,Paclitaxel, Carboplatin in people with Esophageal Cancer and Gastric Cancer, run by Brown University at 1 site in United States.
Trial summary
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- Cetuximab,Paclitaxel, Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Apr 2010
- 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 are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach.
- Patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric lymphadenopathy.
- There must be no evidence of distant organ metastases.
- No prior radiation for gastric or esophageal cancer.
- Patients must be > 18 years of age, and nonpregnant
- Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2 x upper limit normal (ULN) and bilirubin < 1.5 x ULN, and AST < 3 x ULN.
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- ECOG performance status 0-2.
- Patients must not have significant infection or other coexistent medical condition that would preclude protocol therapy.
- Female patients, must either be not of child bearing potential or have a negative pregnancy test within 7 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible.
- All patients must sign informed consent
Who cannot join
- Any of the following criteria will make the patient ineligible to participate in this study:
- Acute hepatitis or AIDS.
- Active or uncontrolled infection.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
- Prior therapy which specifically and directly targets the EGFR pathway.
- Prior severe infusion reaction to a monoclonal antibody.
- Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University Oncology Group
Providence, Rhode Island, 02912
About this study
Official title: Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
Read the detailed description
The primary objective of this phase II trial is to estimate the rate of complete pathologic response as determined by surgical resection or post treatment endoscopy (for patients not undergoing resection) for the treatment regimen being tested. With a total accrual of 28 evaluable patients.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- Cetuximab,Paclitaxel, Carboplatin
- Keywords
- esophageal cancer, gastroesophageal cancer, gastric cancer
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab,Paclitaxel, CarboplatinDrug
IV treatment for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation. Receives: Drug: Cetuximab,Paclitaxel, Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reponse Rate at Time of Surgery by Tissue
pathologic complete response rate at surgery
Measured: within 30 days of last treatment
Secondary outcomes (1)
Number of Participants With Grade 2 and/or 3 Rash in Patients With Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus, Gastroesophageal Junction, or Stomach.
CTCAE version 3: grade 2 and 3 rash. This is reported as it was the most common toxicity.
Measured: baseline, then during treatment, about 5 weeks through 30 days post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startOct 2004
- Primary completionApr 2010
- Study completionApr 2010
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 Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Brown 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, howard safran, Brown University
- Investigators
- Howard Safran, MD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439608
- Sponsor's protocol ID
- BrUOG-EG-203
- Other IDs
- BMS#CA225091
- Status last verified
- Feb 2020
- First submitted
- 22 Feb 2007
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091
- ClinicalTrials.gov ID
- NCT00439608
- Acronym / sponsor ID
- BrUOG-EG-203
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- esophageal cancer, gastroesophageal cancer, gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Oct 2004
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Posted 1 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
Detailed description
The primary objective of this phase II trial is to estimate the rate of complete pathologic response as determined by surgical resection or post treatment endoscopy (for patients not undergoing resection) for the treatment regimen being tested. With a total accrual of 28 evaluable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Cetuximab,Paclitaxel, CarboplatinCetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach.
- Patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric lymphadenopathy.
- There must be no evidence of distant organ metastases.
- No prior radiation for gastric or esophageal cancer.
- Patients must be > 18 years of age, and nonpregnant
Key exclusion criteria (7 listed)
- Any of the following criteria will make the patient ineligible to participate in this study:
- Acute hepatitis or AIDS.
- Active or uncontrolled infection.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
- Prior therapy which specifically and directly targets the EGFR pathway.
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,Paclitaxel, CarboplatinIV treatment for 6 weeks | Drug | Treatment |
Primary outcome
Reponse Rate at Time of Surgery by Tissue
Time frame: within 30 days of last treatment
pathologic complete response rate at surgery
1 secondary outcome
Number of Participants With Grade 2 and/or 3 Rash in Patients With Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus, Gastroesophageal Junction, or Stomach.
Time frame: baseline, then during treatment, about 5 weeks through 30 days post treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Howard Safran, MD principal investigator
Brown 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,Paclitaxel, Carboplatin in people with Esophageal Cancer and Gastric Cancer, run by Brown University at 1 site 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 10 inclusion and 7 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 17 Feb 2020. 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 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 1 Jul 2013). 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?
Reponse Rate at Time of Surgery by Tissue (time frame: within 30 days of last treatment). 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 17 Feb 2020.