Esophageal AdenocarcinomaNCT00430027
Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma
A study testing Capecitabine, Oxaliplatin and Cetuximab in people with Esophageal Adenocarcinoma, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection [and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab] is feasible and tolerable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Adenocarcinoma
- What is being tested?
- Capecitabine, Oxaliplatin and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Aug 2008
- Phase
- Interventional
- 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
- signed informed consent
- patients 18 years of age or older
- biopsy proven, non-recurrent primary adenocarcinoma of the thoracic esophagus or gastro-esophageal junction, disease confined to esophagus and peri-esophageal soft tissue, tumors at the gastroesophageal junction must be limited to no greater than 2 cm into the gastric cardia
- clinical stage T3, N0-1 or T1-2, N1 and M0 or M1a (celiac axis lymph nodes are allowed)
- Karnofsky Performance Status of >60%
- forced expiratory volume at one second (FeV1) must be >1.0 L
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- adequate bone marrow reserve equal to or absolute neutrophil count (ANC) > 1500/mcl, total white blood cell count (WBC) > 3000/mcl, platelets >100,000/mcl and hemoglobin > 10.0 g/dl (transfusion permitted)
- adequate hepatic function of direct serum bilirubin < 2 times the upper limit of normal, total bilirubin < 1.5 times the upper limit normal, alanine transaminase (ALT), aspartate transaminase (AST) < 2.5 times the upper limit normal, Alkaline phosphatase < 2.5 times the upper limit normal
- creatinine clearance > 50 ml/min
- female patients of childbearing potential must have a negative serum or urin pregnancy test within 7 days prior to starting therapy
Who cannot join
- no previous resection or attempted resection of an esophageal cancer
- women who are pregnant or lactating
- life expectancy < 3 months
- serious, uncontrolled concurrent infection(s)
- prior fluoropyrimidine therapy
- prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known Dihydro Pyrimidine Dehydrogenase Deficiency (DPD) deficiency
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- treatment for other carcinomas within 5 years, except cured non-melanoma skin and treated in-situ cervical cancer
- history of or evidence of uncontrolled diabetes
- surgical procedure within 6 months of study entry
- participation in any investigational drug study within 4 weeks preceding the start of study treatment
- prior therapy with andy agent that specifically targets the Epidermal Growth Factor Receptor (EGFR) pathway
- prior severe infusion reaction to a monoclonal antibody
- acute hepatitis or known HIV
- clinically significant cardia disease
- evidence of metastases
- other serious uncontrolled medical conditions that the investigator feels might compromise study participation
- major surgery within 4 weeks of the start of treatment without complete recovery
- lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- known, existing uncontrolled coagulopathy
- unwillingness to give written informed consent
- unwillingness to participate or inability to comply with the protocol for the duration of the study
- neuropathy of grade 2 or greater
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Denver and Health Science Center
Aurora, Colorado, 80045
About this study
Official title: Pilot Feasibility Trial of Preoperative Capecitabine, Oxaliplatin, Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma
The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection [and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab] is feasible and tolerable.
Read the detailed description
It is clear that new approaches are needed to improve the therapeutic ratio in esophageal cancer. This study proposes to evaluate the novel combination of preoperative capecitabine, oxaliplatin, and cetuximab concurrently with radiation therapy. This will be followed by esophagectomy 6-9 weeks after the completion of chemoradiation. Followed by further adjuvant chemotherapy. It is hypothesized that our novel combination of neoadjuvant capecitabine, oxaliplatin, and cetuximab combined with thoracoabdominal radiation therapy will be feasible and result in acceptable toxicity.
- Conditions
- Esophageal Adenocarcinoma
- Being tested
- Capecitabine, Oxaliplatin, Cetuximab
- Keywords
- Esophageal, Esophagus
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Given 650 mg/m^2 BID on days of ration therapy, 825 mg/m^2 day 1-14, day 15-20 off x 4
OxaliplatinDrug
Also called Eloxatin
Oxaliplatin 30 mg/m^2, 130mg/m2 IV Q 21 days x 4
CetuximabDrug
Also called Erbitux
Initial Cetuximab 400 mg/m^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine, oxaliplatin, cetuximab, and radiation therapy | Experimental | Patients enrolled on the trial will receive neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This will be followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Toxicity
The primary objective of this pilot study was to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab is feasible with acceptable toxicity profile.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startNov 2006
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: This study was terminated due slow accrual.
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 AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Sanofi
- Responsible party
- Sponsor
- Investigators
- Tracey Schefter, MD, Principal investigator, University of Colorado at Denver and Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430027
- Sponsor's protocol ID
- 06-0011.cc
- Status last verified
- Oct 2013
- First submitted
- 30 Jan 2007
- Last updated
- 12 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Trial of Preoperative Capecitabine, Oxaliplatin, Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00430027
- Acronym / sponsor ID
- 06-0011.cc
- Conditions
- Esophageal Adenocarcinoma
- Keywords
- Esophageal, Esophagus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due slow accrual.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Sanofi
- Study start
- Nov 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Posted 12 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection [and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab] is feasible and tolerable.
Detailed description
It is clear that new approaches are needed to improve the therapeutic ratio in esophageal cancer. This study proposes to evaluate the novel combination of preoperative capecitabine, oxaliplatin, and cetuximab concurrently with radiation therapy. This will be followed by esophagectomy 6-9 weeks after the completion of chemoradiation. Followed by further adjuvant chemotherapy. It is hypothesized that our novel combination of neoadjuvant capecitabine, oxaliplatin, and cetuximab combined with thoracoabdominal radiation therapy will be feasible and result in acceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine, oxaliplatin, cetuximab, and radiation therapy | Experimental | Drug: Capecitabine, Drug: Oxaliplatin, Drug: CetuximabPatients enrolled on the trial will receive neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This will be followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- signed informed consent
- patients 18 years of age or older
- biopsy proven, non-recurrent primary adenocarcinoma of the thoracic esophagus or gastro-esophageal junction, disease confined to esophagus and peri-esophageal soft tissue, tumors at the gastroesophageal junction must be limited to no greater than 2 cm into the gastric cardia
- clinical stage T3, N0-1 or T1-2, N1 and M0 or M1a (celiac axis lymph nodes are allowed)
- Karnofsky Performance Status of >60%
Key exclusion criteria (22 listed)
- no previous resection or attempted resection of an esophageal cancer
- women who are pregnant or lactating
- life expectancy < 3 months
- serious, uncontrolled concurrent infection(s)
- prior fluoropyrimidine therapy
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 |
|---|---|---|
| CapecitabineAlso: XelodaGiven 650 mg/m^2 BID on days of ration therapy, 825 mg/m^2 day 1-14, day 15-20 off x 4 | Drug | Capecitabine, oxaliplatin, cetuximab, and radiation therapy |
| OxaliplatinAlso: EloxatinOxaliplatin 30 mg/m^2, 130mg/m2 IV Q 21 days x 4 | Drug | Capecitabine, oxaliplatin, cetuximab, and radiation therapy |
| CetuximabAlso: ErbituxInitial Cetuximab 400 mg/m^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection | Drug | Capecitabine, oxaliplatin, cetuximab, and radiation therapy |
Primary outcome
Overall Toxicity
Time frame: Up to 4 weeks
The primary objective of this pilot study was to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab is feasible with acceptable toxicity profile.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tracey Schefter, MD principal investigator
University of Colorado at Denver and Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capecitabine, Oxaliplatin and Cetuximab in people with Esophageal Adenocarcinoma, run by University of Colorado, Denver 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 22 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 12 Dec 2013. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 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?
Overall Toxicity (time frame: Up to 4 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 12 Dec 2013.