Colorectal CancerNCT00608595
Celecoxib in Treating Patients With Early-Stage Rectal Cancer
A study testing celecoxib, gene expression analysis and protein expression analysis in people with Colorectal Cancer, run by Vanderbilt-Ingram Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how rectal cancer will respond to treatment with celecoxib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- celecoxib, gene expression analysis and protein expression analysis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2002to Apr 2008
- Phase
- Interventional
- 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
- Clinical diagnosis of primary adenocarcinoma of the rectum (to be histologically confirmed upon study entry)
- Tumor must be at or below the peritoneal reflection
- The distal border of the tumor is within 12 cm of the anal verge on proctoscopic examination
- Clinically resectable disease
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
Show all 15Show fewer
- WBC ≥ 4,000/mm³
- Platelet count ≥ 150,000/mm³
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other serious medical illness (other than rectal cancer) that would preclude study therapy
- No psychiatric condition that would preclude informed consent
- No history of allergy to celecoxib or any other NSAIDs, including acetylsalicylic acid (i.e., aspirin), ibuprofen, or indomethacin
- No history of allergy to sulfonamides
Who cannot join
- Not noted
- PRIOR CONCURRENT THERAPY:
- At least 7 days since prior and no concurrent NSAIDs or other cyclooxygenase-2 inhibitors
- No concurrent warfarin, except low-dose warfarin (i.e., 1 mg/day) administered for prophylaxis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans Administration
Nashville, Tennessee, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE)
RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how rectal cancer will respond to treatment with celecoxib.
PURPOSE: This clinical trial is studying how well celecoxib works in treating patients with early-stage rectal cancer.
Read the detailed description
OBJECTIVES:
- Determine cyclooxygenase-2 (COX-2) over-expression in tumor specimens from patients with early-stage rectal cancer.
- Determine whether administration of a COX-2 inhibitor, celecoxib, results in changes in tumor (COX-2 overexpressing) levels of eicosanoids but not in levels in the surrounding normal tissue that is expected not to express COX-2.
- Determine whether surrogate markers of eicosanoid metabolism (i.e., serum VEGF levels, tumor prostaglandin E_2 [PGE_2], and the major urinary metabolite of PGE_2 [PGE-M]) in biological specimens from these patients correlate with changes noted in tumor tissue.
- Determine if there is a greater change in protein and gene expression from pretreatment biopsy levels in patient tumor specimens (COX-2 overexpressing) vs specimens of surrounding normal tissue (expected not to be COX-2 overexpressing).
OUTLINE: Patients receive oral celecoxib twice daily on days 1-5. Patients then undergo planned local excision or definitive radical resection on day 6.
Tumor tissue and normal tissue (at least 5 cm away from the tumor) samples are collected pretreatment. Post-treatment tissue samples are collected along with the surgery. Serum and urine samples are obtained at baseline and after administration of celecoxib. Tumor and normal tissue specimens are analyzed by assays measuring markers of cyclooxygenase-2 (COX-2) activity (i.e., COX-2 mRNA and protein, tumor prostaglandin E_2 [PGE_2], and VEGF). Tissue samples are also assessed by cDNA microarray and imaging mass spectrometry to determine overall changes in gene and protein expression from pretreatment levels. Surrogate markers of COX-2 activity in serum (i.e., VEGF) and urine (i.e., urinary metabolite of PGE_2 [PGE-M]) are also assessed and compared with changes noted in tumor tissue. COX-2 protein levels are determined by immunohistochemistry in patients with limited pretreatment tumor tissue specimens.
- Conditions
- Colorectal Cancer
- Being tested
- celecoxib, gene expression analysis, protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- adenocarcinoma of the rectum, recurrent rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Also called Celebrex
Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.
gene expression analysisGenetic
not noted
protein expression analysisGenetic
Not noted
immunohistochemistry staining methodOther
not noted
laboratory biomarker analysisOther
not noted
mass spectrometryOther
biopsyProcedure or surgery
At the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib.
neoadjuvant therapyProcedure or surgery
not noted
therapeutic conventional surgeryProcedure or surgery
not noted
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Intervention/Celecoxib | Experimental | Celecoxib Receives: Drug: celecoxib; Genetic: gene expression analysis; Genetic: protein expression analysis; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: mass spectrometry; Procedure: biopsy; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event rate of over-expression of cyclooxygenase-2
Measured: Pre and post 7 days administration of study drug
Percent change of eicosanoid level
Measured: Pre and post celecoxib treatment ratio of eicosanoid production
Percent change of VEGF and prostaglandin-M levels
Measured: Pre and post celecoxib treatment VEGF and PGE-M levels
Change of gene and protein expression pattern from pre- to post-treatment levels
Measured: Pre and post celecoxib treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJul 2002
- Primary completionMay 2004
- Study completionApr 2008
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- A. Bapsi Chakravarthy, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608595
- Sponsor's protocol ID
- VICC GI 0174
- Other IDs
- VU-VICC-GI-0174
- Status last verified
- Mar 2013
- First submitted
- 30 Jan 2008
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE)
- ClinicalTrials.gov ID
- NCT00608595
- Acronym / sponsor ID
- VICC GI 0174
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the rectum, recurrent rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2002
- Primary completion
- May 2004 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Feb 2008 (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: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how rectal cancer will respond to treatment with celecoxib.
PURPOSE: This clinical trial is studying how well celecoxib works in treating patients with early-stage rectal cancer.
Detailed description
OBJECTIVES:
- Determine cyclooxygenase-2 (COX-2) over-expression in tumor specimens from patients with early-stage rectal cancer.
- Determine whether administration of a COX-2 inhibitor, celecoxib, results in changes in tumor (COX-2 overexpressing) levels of eicosanoids but not in levels in the surrounding normal tissue that is expected not to express COX-2.
- Determine whether surrogate markers of eicosanoid metabolism (i.e., serum VEGF levels, tumor prostaglandin E_2 [PGE_2], and the major urinary metabolite of PGE_2 [PGE-M]) in biological specimens from these patients correlate with changes noted in tumor tissue.
- Determine if there is a greater change in protein and gene expression from pretreatment biopsy levels in patient tumor specimens (COX-2 overexpressing) vs specimens of surrounding normal tissue (expected not to be COX-2 overexpressing).
OUTLINE: Patients receive oral celecoxib twice daily on days 1-5. Patients then undergo planned local excision or definitive radical resection on day 6.
Tumor tissue and normal tissue (at least 5 cm away from the tumor) samples are collected pretreatment. Post-treatment tissue samples are collected along with the surgery. Serum and urine samples are obtained at baseline and after administration of celecoxib. Tumor and normal tissue specimens are analyzed by assays measuring markers of cyclooxygenase-2 (COX-2) activity (i.e., COX-2 mRNA and protein, tumor prostaglandin E_2 [PGE_2], and VEGF). Tissue samples are also assessed by cDNA microarray and imaging mass spectrometry to determine overall changes in gene and protein expression from pretreatment levels. Surrogate markers of COX-2 activity in serum (i.e., VEGF) and urine (i.e., urinary metabolite of PGE_2 [PGE-M]) are also assessed and compared with changes noted in tumor tissue. COX-2 protein levels are determined by immunohistochemistry in patients with limited pretreatment tumor tissue specimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Intervention/Celecoxib | Experimental | Drug: celecoxib, Genetic: gene expression analysis, Genetic: protein expression analysis, Other: immunohistochemistry staining method, Other: laboratory biomarker analysis, Other: mass spectrometry, Procedure: biopsy, Procedure: neoadjuvant therapy, Procedure: therapeutic conventional surgeryCelecoxib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Clinical diagnosis of primary adenocarcinoma of the rectum (to be histologically confirmed upon study entry)
- Clinically resectable disease
- Karnofsky performance status 60-100%
- WBC ≥ 4,000/mm³
- Platelet count ≥ 150,000/mm³
Key exclusion criteria (4 listed)
- Not noted
- At least 7 days since prior and no concurrent NSAIDs or other cyclooxygenase-2 inhibitors
- No concurrent warfarin, except low-dose warfarin (i.e., 1 mg/day) administered for prophylaxis
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 |
|---|---|---|
| celecoxibAlso: CelebrexWill be administered orally 400 mg po BID starting 5 days prior to planned surgical resection. | Drug | Therapeutic Intervention/Celecoxib |
| gene expression analysisnot noted | Genetic | Therapeutic Intervention/Celecoxib |
| protein expression analysisNot noted | Genetic | Therapeutic Intervention/Celecoxib |
| immunohistochemistry staining methodnot noted | Other | Therapeutic Intervention/Celecoxib |
| laboratory biomarker analysisnot noted | Other | Therapeutic Intervention/Celecoxib |
| mass spectrometry | Other | Therapeutic Intervention/Celecoxib |
| biopsyAt the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib. | Procedure or surgery | Therapeutic Intervention/Celecoxib |
| neoadjuvant therapynot noted | Procedure or surgery | Therapeutic Intervention/Celecoxib |
| therapeutic conventional surgerynot noted | Procedure or surgery | Therapeutic Intervention/Celecoxib |
Primary outcome
Event rate of over-expression of cyclooxygenase-2
Time frame: Pre and post 7 days administration of study drug
Percent change of eicosanoid level
Time frame: Pre and post celecoxib treatment ratio of eicosanoid production
Percent change of VEGF and prostaglandin-M levels
Time frame: Pre and post celecoxib treatment VEGF and PGE-M levels
Change of gene and protein expression pattern from pre- to post-treatment levels
Time frame: Pre and post celecoxib treatment
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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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.
A. Bapsi Chakravarthy, MD principal investigator
Vanderbilt-Ingram Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing celecoxib, gene expression analysis and protein expression analysis in people with Colorectal Cancer, run by Vanderbilt-Ingram Cancer Center 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 15 inclusion and 4 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 5 Mar 2013. 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.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
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?
Event rate of over-expression of cyclooxygenase-2 (time frame: Pre and post 7 days administration of study drug). The study lists 4 primary outcomes in all. 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 5 Mar 2013.