Esophageal CancerPhase 2NCT00066716
Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
A Phase 2 study testing carboplatin, celecoxib and paclitaxel in people with Esophageal Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. 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?
- carboplatin, celecoxib and paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to May 2007
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed esophageal cancer of 1 of the following cellular types:
- Squamous cell
- Adenocarcinoma
- Potentially resectable disease
- No distant metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 80-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- No bleeding disorder
Hepatic
- Bilirubin normal
- AST and ALT less than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- No significant history of unstable cardiovascular disease
- No inadequately controlled hypertension
- No angina
- No myocardial infarction within the past 6 months
- No ventricular cardiac arrhythmias requiring medication
- No congestive heart failure that would preclude study therapy
Pulmonary
- Pulmonary function acceptable for surgery
- No interstitial pneumonia
- No interstitial fibrosis
Gastrointestinal
- No history of peptic ulcer disease
- No irritable bowel syndrome
- No inflammatory bowel disease
- No chronic diarrhea
- No bowel obstruction within the past 5 years
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates
- No hypersensitivity to paclitaxel or carboplatin
- No other serious underlying medical condition that would preclude study therapy
- No significant psychiatric illness that would preclude study compliance
- No uncontrolled diabetes mellitus
- No uncontrolled infection
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No concurrent chronic steroid use except inhaled mometasone or fluticasone
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 3 weeks since other prior clinical trial therapy
- At least 72 hours since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
- No concurrent chronic NSAID use (7 or more days of continuous therapy per month OR 3 or more days of therapy per week)
- No other concurrent investigational agents
- No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin or phenobarbital)
- No other concurrent cyclo-oxygenase (COX)-2 inhibitors
- No concurrent lithium or fluconazole
- Concurrent low-dose aspirin (325 mg/day or less) allowed for cardiovascular prophylaxis
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
About this study
Official title: A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. Celecoxib may also stop the growth of tumor cells by stopping blood flow to the tumor and/or may block the enzymes necessary for their growth. Combining celecoxib with paclitaxel and carboplatin before surgery may shrink the tumor so that it can be removed during surgery. Giving celecoxib alone after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving celecoxib together with paclitaxel and carboplatin works in treating patients who are undergoing surgery for esophageal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the rate of complete pathological response and/or minimal residual microscopic disease in patients with squamous cell or adenocarcinoma of the esophagus treated with preoperative celecoxib, paclitaxel, and carboplatin.
Secondary
- Determine the clinical response rate of patients treated with this regimen.
- Determine the chemotherapy-related toxicity of this regimen in these patients.
- Determine the time to progression, disease-free survival, and overall survival of patients treated with this regimen.
OUTLINE: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1, 22, and 43. Patients also receive oral celecoxib twice daily beginning 3-7 days before the first dose of chemotherapy and continuing until the morning of planned surgical resection (between days 64 and 71). Approximately 28-56 days after resection, patients may resume oral celecoxib twice daily and continue for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed periodically for 18 months after surgery.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 18 months.
- Conditions
- Esophageal Cancer
- Being tested
- carboplatin, celecoxib, paclitaxel, adjuvant therapy, conventional surgery
- Keywords
- adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer (lymph node metastasis only)
- Medical subject headings
- Esophageal Neoplasms, 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.
carboplatinDrug
Dosed to an AUC of 6 by the Calvert formula, intravenously over 1 hour after paclitaxel on days 1, 22, and 43.
celecoxibDrug
Also called Celebrex
400 mg orally BID begins 3-7 days before the first dose of chemotherapy to the morning of surgery. Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year total, that is, 1 year from the date of surgery + 2 weeks unless tumor recurrence is documented.
paclitaxelDrug
Also called Taxol
200 mg/m2 as a 3-hour intravenous infusion on days 1, 22, and 43.
adjuvant therapyProcedure or surgery
- Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin.
- Operation will be performed within 6-12 hours from the last dose of celecoxib.
- Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection.
- Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year.
conventional surgeryProcedure or surgery
- Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin.
- Operation will be performed within 6-12 hours from the last dose of celecoxib.
- Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection.
neoadjuvant therapyProcedure or surgery
- Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin.
- Operation will be performed within 6-12 hours from the last dose of celecoxib.
- Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response rate at time of surgical resection
Measured: At completion of pathology report.
Secondary outcomes (4)
Clinical response rate
Measured: At the time of tumor assessment obtained prior to definitive surgery approximately 1-2 weeks prior to surgical resection.
Disease-free survival
Measured: From start of treatment to time of recurrent disease measured postoperatively every 6 months for 18 months.
Overall survival
Measured: 18 months after surgery
Toxicities and safety
Measured: 30 days after completion of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study startJun 2003
- Primary completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Nasser K. Altorki, MD, Study chair, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066716
- Sponsor's protocol ID
- CDR0000316464
- Other IDs
- NYWCCC-0902-463
- Status last verified
- Dec 2009
- First submitted
- 6 Aug 2003
- Last updated
- 8 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus
- ClinicalTrials.gov ID
- NCT00066716
- Acronym / sponsor ID
- CDR0000316464
- Conditions
- Esophageal Cancer
- Keywords
- adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer (lymph node metastasis only)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2003
- Primary completion
- May 2007 (actual)
- First posted
- 7 Aug 2003 (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.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. Celecoxib may also stop the growth of tumor cells by stopping blood flow to the tumor and/or may block the enzymes necessary for their growth. Combining celecoxib with paclitaxel and carboplatin before surgery may shrink the tumor so that it can be removed during surgery. Giving celecoxib alone after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving celecoxib together with paclitaxel and carboplatin works in treating patients who are undergoing surgery for esophageal cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the rate of complete pathological response and/or minimal residual microscopic disease in patients with squamous cell or adenocarcinoma of the esophagus treated with preoperative celecoxib, paclitaxel, and carboplatin.
Secondary
- Determine the clinical response rate of patients treated with this regimen.
- Determine the chemotherapy-related toxicity of this regimen in these patients.
- Determine the time to progression, disease-free survival, and overall survival of patients treated with this regimen.
OUTLINE: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1, 22, and 43. Patients also receive oral celecoxib twice daily beginning 3-7 days before the first dose of chemotherapy and continuing until the morning of planned surgical resection (between days 64 and 71). Approximately 28-56 days after resection, patients may resume oral celecoxib twice daily and continue for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed periodically for 18 months after surgery.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 18 months.
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
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 |
|---|---|---|
| carboplatinDosed to an AUC of 6 by the Calvert formula, intravenously over 1 hour after paclitaxel on days 1, 22, and 43. | Drug | – |
| celecoxibAlso: Celebrex400 mg orally BID begins 3-7 days before the first dose of chemotherapy to the morning of surgery. Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year total, that is, 1 year from the date of surgery + 2 weeks unless tumor recurrence is documented. | Drug | – |
| paclitaxelAlso: Taxol200 mg/m2 as a 3-hour intravenous infusion on days 1, 22, and 43. | Drug | – |
| adjuvant therapy1. Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin. 2. Operation will be performed within 6-12 hours from the last dose of celecoxib. 3. Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection. 4. Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year. | Procedure or surgery | – |
| conventional surgery1. Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin. 2. Operation will be performed within 6-12 hours from the last dose of celecoxib. 3. Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection. | Procedure or surgery | – |
| neoadjuvant therapy1. Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin. 2. Operation will be performed within 6-12 hours from the last dose of celecoxib. 3. Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection. | Procedure or surgery | – |
Primary outcome
Pathological response rate at time of surgical resection
Time frame: At completion of pathology report.
4 secondary outcomes
Clinical response rate
Time frame: At the time of tumor assessment obtained prior to definitive surgery approximately 1-2 weeks prior to surgical resection.
Disease-free survival
Time frame: From start of treatment to time of recurrent disease measured postoperatively every 6 months for 18 months.
Overall survival
Time frame: 18 months after surgery
Toxicities and safety
Time frame: 30 days after completion of study treatment.
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 8 Dec 2009.
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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.
Nasser K. Altorki, MD study chair
Weill Medical College of Cornell 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 carboplatin, celecoxib and paclitaxel in people with Esophageal Cancer, run by Weill Medical College of Cornell 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?
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 8 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 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?
Pathological response rate at time of surgical resection (time frame: At completion of pathology report.). 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 8 Dec 2009.