Adenocarcinoma of EsophagusPhase 2NCT00165490
Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer
A Phase 2 study testing Cetuximab, Cisplatin and Irinotecan in people with Adenocarcinoma of Esophagus and Squamous Cell Carcinoma of Esophagus, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is to find out what effects (good and bad) the combination of three chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when given with radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of Esophagus, Squamous Cell Carcinoma of Esophagus
- What is being tested?
- Cetuximab, Cisplatin and Irinotecan
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to Nov 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Negative pregnancy test
- Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, stage IIA, IIB and III.
- ECOG performance status of 0 or 1.
- Neutrophils greater or equal to 1,500/ul
- Platelets greater or equal to 100,000/ul
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- Serum bilirubin less or equal to 1.5mg/ul
- Serum creatinine less or equal to 1.5mg/ul
- AST or SGOT less or equal to 2.5x upper normal limit
- Alkaline phosphatase less or equal to 5x upper normal limit
Who cannot join
- Prior surgery for esophageal or gastro-esophageal junction cancer.
- Prior chemotherapy or radiation therapy
- Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula.
- Metastatic disease to distant organs or non-regional lymph nodes.
- Co-morbid disease that in the opinion of the investigator makes combined chemo-radiotherapy inadvisable.
- Pregnant or lactating women
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- Other active malignancy
- Patients with known Gilbert's Disease or interstitial pulmonary fibrosis.
- History of seizure disorder
- Uncontrolled diarrhea
- Peripheral neuropathy (Grade 2)
- Prior cetuximab or other therapy that specifically and directly targets the EGF pathway.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: Phase II Trial of Cetuximab, Irinotecan, Cisplatin (CPC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer
The purpose of this study is to find out what effects (good and bad) the combination of three chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when given with radiation therapy.
Read the detailed description
- Patients participating in this study must have a tumor biopsy taken to confirm the type of tumor.
- Outpatient therapy with cetuximab alone will be given intravenously on week 0.
- During week 1-8 outpatient radiation therapy will be started and continued once per day for 28 treatments or 5 1/2 weeks.
- Outpatient chemotherapy (cisplatin, irinotecan and cetuximab) is given once per week on weeks 1, 2, 4, and 5. Cetuximab alone will be given on weeks 3, 6, 7, and 8.
- A repeat CT scan and PET scan will be performed to restage the tumor on week 8. This is to confirm that the cancer has remained localized.
- Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and radiation therapy.
- Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6 months.
- During chemotherapy and radiation therapy, physical exams and vital signs will be performed before each chemotherapy treatment. Routine blood tests will also be performed.
- Between chemotherapy-radiation therapy and surgery a CAT scan of chest, abdomen and pelvis along with a PET scan will be performed.
- After surgery a CAT scan of chest, abdomen and pelvis will be performed every 3 months for 2 years then every 6 months for 3 years. An EGD (upper endoscopy) with biopsy will be done every 6 months for 2 years and then yearly for 3 years. Physical exam, vital signs and routine blood tests will be done every 2 weeks for 6 months, then every 3 months for 1.5 years, and then every 6 months for 3 years.
- Being tested
- Cetuximab, Cisplatin, Irinotecan, Radiation therapy, Surgery
- Keywords
- adenocarcinoma of esophagus, squamous cell carcinoma of esophagus, combination chemotherapy, cisplatin, irinotecan, radiation therapy, resectable esophageal cancer
- Medical subject headings
- Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Given once per week on weeks 1-8 and restarted 4 weeks after surgery, once weekly for 6 months.
CisplatinDrug
Given once per week on weeks 1, 2, 4,and 5.
IrinotecanDrug
Given once per week on weeks 1, 2, 4,and 5.
Radiation therapyDevice
Once daily for 28 treatments (5 1/2 weeks)
SurgeryProcedure or surgery
Surgery performed 4-8 weeks after chemoradiation therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma.
Measured: 3 years
Secondary outcomes (2)
To determine the safety of the drug combination and radiation therapy
Measured: 3 years
To determine the progression-free survival of patients treated with combination chemotherapy and radiation therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionNov 2007
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of EsophagusStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Peter C. Enzinger, MD, Dana-Farber Cancer Institute
- Investigators
- Peter Enzinger, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165490
- Sponsor's protocol ID
- 02-012
- Status last verified
- Nov 2014
- First submitted
- 9 Sep 2005
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Cetuximab, Irinotecan, Cisplatin (CPC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00165490
- Acronym / sponsor ID
- 02-012
- Keywords
- adenocarcinoma of esophagus, squamous cell carcinoma of esophagus, combination chemotherapy, cisplatin, irinotecan, radiation therapy, resectable esophageal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Aug 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Sep 2005 (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 find out what effects (good and bad) the combination of three chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when given with radiation therapy.
Detailed description
- Patients participating in this study must have a tumor biopsy taken to confirm the type of tumor.
- Outpatient therapy with cetuximab alone will be given intravenously on week 0.
- During week 1-8 outpatient radiation therapy will be started and continued once per day for 28 treatments or 5 1/2 weeks.
- Outpatient chemotherapy (cisplatin, irinotecan and cetuximab) is given once per week on weeks 1, 2, 4, and 5. Cetuximab alone will be given on weeks 3, 6, 7, and 8.
- A repeat CT scan and PET scan will be performed to restage the tumor on week 8. This is to confirm that the cancer has remained localized.
- Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and radiation therapy.
- Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6 months.
- During chemotherapy and radiation therapy, physical exams and vital signs will be performed before each chemotherapy treatment. Routine blood tests will also be performed.
- Between chemotherapy-radiation therapy and surgery a CAT scan of chest, abdomen and pelvis along with a PET scan will be performed.
- After surgery a CAT scan of chest, abdomen and pelvis will be performed every 3 months for 2 years then every 6 months for 3 years. An EGD (upper endoscopy) with biopsy will be done every 6 months for 2 years and then yearly for 3 years. Physical exam, vital signs and routine blood tests will be done every 2 weeks for 6 months, then every 3 months for 1.5 years, and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age or older
- Negative pregnancy test
- Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, stage IIA, IIB and III.
- ECOG performance status of 0 or 1.
- Neutrophils greater or equal to 1,500/ul
Key exclusion criteria (12 listed)
- Prior surgery for esophageal or gastro-esophageal junction cancer.
- Prior chemotherapy or radiation therapy
- Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula.
- Metastatic disease to distant organs or non-regional lymph nodes.
- Co-morbid disease that in the opinion of the investigator makes combined chemo-radiotherapy inadvisable.
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 |
|---|---|---|
| CetuximabGiven once per week on weeks 1-8 and restarted 4 weeks after surgery, once weekly for 6 months. | Drug | – |
| CisplatinGiven once per week on weeks 1, 2, 4,and 5. | Drug | – |
| IrinotecanGiven once per week on weeks 1, 2, 4,and 5. | Drug | – |
| Radiation therapyOnce daily for 28 treatments (5 1/2 weeks) | Device | – |
| SurgerySurgery performed 4-8 weeks after chemoradiation therapy. | Procedure or surgery | – |
Primary outcome
To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma.
Time frame: 3 years
2 secondary outcomes
To determine the safety of the drug combination and radiation therapy
Time frame: 3 years
To determine the progression-free survival of patients treated with combination chemotherapy and radiation therapy.
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 10 Nov 2014.
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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.
Peter Enzinger, MD principal investigator
Dana-Farber Cancer Institute
2 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 Cetuximab, Cisplatin and Irinotecan in people with Adenocarcinoma of Esophagus and Squamous Cell Carcinoma of Esophagus, run by Dana-Farber Cancer Institute at 2 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 10 inclusion and 12 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 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma. (time frame: 3 years). 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 10 Nov 2014.