Esophageal CancerPhase 2NCT00137852
Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer
A Phase 2 study testing Cisplatin, Irinotecan and Celecoxib in people with Esophageal Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This is a study for patients with resectable, locally advanced esophageal cancer. There is evidence to suggest that celecoxib in combination with cisplatin and irinotecan (CPT-11) may work well with radiation therapy to kill cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Cisplatin, Irinotecan and Celecoxib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2002to Sep 2017
- 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
- Age greater than or equal to 18 years.
- Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, American Joint Committee on Cancer (AJCC) Stage IIA, IIB, III. Additionally, patients with tumors of the lower thoracic esophagus and gastroesophageal junction may have regional lymph node involvement (M1A-Stage IVA), as long as the lymphadenopathy can be entirely encompassed by the radiation field.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Neutrophils greater than or equal to 1,500/ μL.
- Platelets greater than or equal to 100,000/ μL.
- Serum bilirubin less than or equal to 1.5 mg/dl.
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- Serum creatinine less than or equal to 1.5 mg/dl.
- Aspartamine transaminase (AST or SGOT) less than or equal to 3x upper institutional normal limit.
- Alkaline phosphatase less than or equal to 5x upper institutional normal limit.
Who cannot join
- No prior surgery for esophageal or gastro-esophageal junction cancer.
- No prior chemotherapy or radiation therapy.
- Biopsy proven tumor invasion of the tracheobronchial tree or a tracheoesophageal fistula.
- Metastatic disease to distant organs (e.g. liver, lungs, bone) or non-regional lymph nodes. Patients with supraclavicular/cervical lymph node involvement or patients with a proximal esophageal primary and celiac/gastro-hepatic lymph node involvement are also excluded.
- Patients with co-morbid disease that, in the opinion of the investigator, makes combined chemo-radiotherapy inadvisable (e.g. New York State Grade III-IV heart disease, myocardial infarction in the last 4 months, uncontrolled infection, uncontrolled diabetes, uncontrolled hypertension, uncontrolled psychiatric illness or organ allograft(s) on immunosuppressive therapy).
- Pregnant or lactating women or women of childbearing potential with either a positive or no pregnancy test at baseline.
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- Women of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.)
- Other active malignancy (i.e. hematologic malignancy, metastatic solid tumor, or resected Stage I-IV solid tumor less than 3 years after resection).
- Patients with known Gilbert's disease or interstitial pulmonary fibrosis.
- Patients with prior severe reaction to nonsteroidal anti-inflammatory drugs (NSAIDs), sulfonamides, or celecoxib.
- Patients with a history of seizure disorders who are receiving antiepileptic medication.
- Positive malignant cytology of the pleura, pericardium or peritoneum.
- Uncontrolled diarrhea (National Cancer Institute Common Toxicity Criteria [NCI CTC] greater than or equal to Grade 2).
- Peripheral neuropathy (NCI CTC greater than or equal to Grade 2).
- Symptomatic hearing loss, requiring a hearing aid or for which a hearing aid has been suggested by a health professional.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Trial of Cisplatin, CPT-11, Celecoxib (PCC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer
This is a study for patients with resectable, locally advanced esophageal cancer. There is evidence to suggest that celecoxib in combination with cisplatin and irinotecan (CPT-11) may work well with radiation therapy to kill cancer cells. The primary goal is to develop a well-tolerated cancer treatment that has an acceptable response rate.
Read the detailed description
Patients will take celecoxib orally twice daily 3 days prior to radiation therapy and until one week prior to surgery. Celecoxib will then be restarted when the patient is discharged from the hospital following surgery and continued for 26 weeks.
Patients will receive chemotherapy (cisplatin and irinotecan) weekly on weeks 1, 2, 4 and 5 during radiation therapy. Chemotherapy must occur on or before the fifth day of radiation therapy.
Radiation therapy will be performed 5 days a week over a 5.6 week period.
Patients will undergo an esophagectomy within 4-8 weeks of chemotherapy/radiation therapy. Technically accessible lymph nodes will also be removed.
During chemotherapy/radiation therapy, a physical exam and bloodwork will be conducted weekly.
Between chemotherapy/radiation therapy and surgery a physical exam, bloodwork and CT of chest, abdomen, and pelvis should be performed.
After the completion of treatment and surgery, a physical exam and bloodwork should be done every 6 weeks for 6 months, then every 3 months for 1 1/2 years, then every 6 months for 3 years.
- Conditions
- Esophageal Cancer
- Being tested
- Cisplatin, Irinotecan, Celecoxib, Radiation Therapy, Esophagectomy
- Keywords
- Esophageal Cancer, Resectable Esophageal Cancer, Radiation Therapy, Celecoxib, Irinotecan, Cisplatin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Given weekly on weeks 1, 2, 4 and 5 during radiation therapy.
IrinotecanDrug
Also called CPT-11
Given weekly on weeks 1, 2, 4 and 5 during radiation therapy
CelecoxibDrug
Given twice daily 3 days prior to radiation and up until one week prior to surgery. It will then be started again once the participant is released from the hospital following surgery for 26 weeks.
Radiation TherapyProcedure or surgery
5 days a week for 5-6 weeks
EsophagectomyProcedure or surgery
Within 4-8 weeks of chemoradiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin/CPT-11/Celecoxib/XRT/Surgery | Experimental | Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer Receives: Drug: Cisplatin; Drug: Irinotecan; Drug: Celecoxib; Procedure: Radiation Therapy; Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of combination of chemotherapy, radiation therapy and surgery in resectable esophageal carcinoma
Secondary outcomes (1)
Determine the side effects of chemotherapy and radiation therapy in patients with resectable esophageal carcinoma
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startJan 2002
- Primary completionAug 2004
- Study completionSep 2017
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 Esophageal CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Pharmacia
- Responsible party
- Principal investigator, Peter C. Enzinger, MD, Dana-Farber Cancer Institute
- Investigators
- Peter C. Enzinger, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137852
- Sponsor's protocol ID
- 01-229
- Status last verified
- Sep 2017
- First submitted
- 29 Aug 2005
- Last updated
- 20 Sep 2017
- Results posted
- No
Publications
Cleary JM, Mamon HJ, Szymonifka J, Bueno R, Choi N, Donahue DM, Fidias PM, Gaissert HA, Jaklitsch MT, Kulke MH, Lynch TP, Mentzer SJ, Meyerhardt JA, Swanson RS, Wain J, Fuchs CS, Enzinger PC. Neoadjuvant irinotecan, cisplatin, and concurrent radiation therapy with celecoxib for patients with locally advanced esophageal cancer. BMC Cancer. 2016 Jul 13;16:468. doi: 10.1186/s12885-016-2485-9.
PubMed 27412386
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Cisplatin, CPT-11, Celecoxib (PCC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00137852
- Acronym / sponsor ID
- 01-229
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, Resectable Esophageal Cancer, Radiation Therapy, Celecoxib, Irinotecan, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Pharmacia
- Study start
- Jan 2002
- Primary completion
- Aug 2004 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Aug 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.
This is a study for patients with resectable, locally advanced esophageal cancer. There is evidence to suggest that celecoxib in combination with cisplatin and irinotecan (CPT-11) may work well with radiation therapy to kill cancer cells. The primary goal is to develop a well-tolerated cancer treatment that has an acceptable response rate.
Detailed description
Patients will take celecoxib orally twice daily 3 days prior to radiation therapy and until one week prior to surgery. Celecoxib will then be restarted when the patient is discharged from the hospital following surgery and continued for 26 weeks.
Patients will receive chemotherapy (cisplatin and irinotecan) weekly on weeks 1, 2, 4 and 5 during radiation therapy. Chemotherapy must occur on or before the fifth day of radiation therapy.
Radiation therapy will be performed 5 days a week over a 5.6 week period.
Patients will undergo an esophagectomy within 4-8 weeks of chemotherapy/radiation therapy. Technically accessible lymph nodes will also be removed.
During chemotherapy/radiation therapy, a physical exam and bloodwork will be conducted weekly.
Between chemotherapy/radiation therapy and surgery a physical exam, bloodwork and CT of chest, abdomen, and pelvis should be performed.
After the completion of treatment and surgery, a physical exam and bloodwork should be done every 6 weeks for 6 months, then every 3 months for 1 1/2 years, then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin/CPT-11/Celecoxib/XRT/Surgery | Experimental | Drug: Cisplatin, Drug: Irinotecan, Drug: Celecoxib, Procedure: Radiation Therapy, Procedure: EsophagectomyCisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age greater than or equal to 18 years.
- Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, American Joint Committee on Cancer (AJCC) Stage IIA, IIB, III. Additionally, patients with tumors of the lower thoracic esophagus and gastroesophageal junction may have regional lymph node involvement (M1A-Stage IVA), as long as the lymphadenopathy can be entirely encompassed by the radiation field.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Neutrophils greater than or equal to 1,500/ μL.
- Platelets greater than or equal to 100,000/ μL.
Key exclusion criteria (15 listed)
- No prior surgery for esophageal or gastro-esophageal junction cancer.
- No prior chemotherapy or radiation therapy.
- Biopsy proven tumor invasion of the tracheobronchial tree or a tracheoesophageal fistula.
- Metastatic disease to distant organs (e.g. liver, lungs, bone) or non-regional lymph nodes. Patients with supraclavicular/cervical lymph node involvement or patients with a proximal esophageal primary and celiac/gastro-hepatic lymph node involvement are also excluded.
- Patients with co-morbid disease that, in the opinion of the investigator, makes combined chemo-radiotherapy inadvisable (e.g. New York State Grade III-IV heart disease, myocardial infarction in the last 4 months, uncontrolled infection, uncontrolled diabetes, uncontrolled hypertension, uncontrolled psychiatric illness or organ allograft(s) on immunosuppressive 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 |
|---|---|---|
| CisplatinGiven weekly on weeks 1, 2, 4 and 5 during radiation therapy. | Drug | Cisplatin/CPT-11/Celecoxib/XRT/Surgery |
| IrinotecanAlso: CPT-11Given weekly on weeks 1, 2, 4 and 5 during radiation therapy | Drug | Cisplatin/CPT-11/Celecoxib/XRT/Surgery |
| CelecoxibGiven twice daily 3 days prior to radiation and up until one week prior to surgery. It will then be started again once the participant is released from the hospital following surgery for 26 weeks. | Drug | Cisplatin/CPT-11/Celecoxib/XRT/Surgery |
| Radiation Therapy5 days a week for 5-6 weeks | Procedure or surgery | Cisplatin/CPT-11/Celecoxib/XRT/Surgery |
| EsophagectomyWithin 4-8 weeks of chemoradiation therapy | Procedure or surgery | Cisplatin/CPT-11/Celecoxib/XRT/Surgery |
Primary outcome
Response rate of combination of chemotherapy, radiation therapy and surgery in resectable esophageal carcinoma
1 secondary outcome
Determine the side effects of chemotherapy and radiation therapy in patients with resectable esophageal carcinoma
Time frame: 2 years
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 20 Sep 2017.
- Results publication: PubMed 27412386Cleary JM, Mamon HJ, Szymonifka J, Bueno R, Choi N, Donahue DM, Fidias PM, Gaissert HA, Jaklitsch MT, Kulke MH, Lynch TP, Mentzer SJ, Meyerhardt JA, Swanson RS, Wain J, Fuchs CS, Enzinger PC. Neoadjuvant irinotecan, cisplatin, and concurrent radiation therapy with celecoxib for patients with locally advanced esophageal cancer. BMC Cancer. 2016 Jul 13;16:468. doi: 10.1186/s12885-016-2485-9.
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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 C. 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 Cisplatin, Irinotecan and Celecoxib in people with Esophageal Cancer, 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 9 inclusion and 15 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 20 Sep 2017. 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?
Response rate of combination of chemotherapy, radiation therapy and surgery in resectable esophageal carcinoma. 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 NCT00137852, 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 20 Sep 2017; AzTrials last refreshed its copy on 7 Nov 2026.