NCT01284504

Brief Summary

The proposed study aims to investigate how the administration of a drug known to reduce inflammation in humans, Celecoxib, will effect the peri-operative inflammatory response of a patient undergoing primary tumor resection surgery for colon cancer. The proposed project is an exploratory study, and will use data from blood samples and tumor samples to attempt to elucidate the immune and inflammatory response in colon cancer patients undergoing primary resection of their tumors.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

December 8, 2016

Completed
Last Updated

March 16, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

January 25, 2011

Results QC Date

October 15, 2016

Last Update Submit

February 19, 2018

Conditions

Colorectal CancerColon Cancer

Outcome Measures

Primary Outcomes (2)

  • Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling

    2 years

  • Blood Samples Taken Before Initiation of Study, Day of Surgery, Days 1 and 3 Post-op, and 30 Days Post-op. Analyzed for 50 Serum Cytokines, Cell-specific Gene Expression, and TCR Repertoire.

    30 days

Secondary Outcomes (1)

  • Surveys to Evaluate Patient Pain, Fatigue, and Quality of Recovery, Recorded From Day of Surgery to 30 Days Post-op.

    30 days

Study Arms (2)

Celecoxib

EXPERIMENTAL

Celecoxib, 200 mg tab

Drug: Celecoxib

Placebo

PLACEBO COMPARATOR

placebo, tab

Other: placebo

Interventions

CelecoxibDRUG

200 mg tablet oral

Also known as: Celebrex, Celebra, Onsenal
Celecoxib
placeboOTHER

Placebo, tab

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Colon cancer patients with no evidence of metastasis in distant organs (i.e., TNM stage I-III), who are
  • between 18 and 75 years old,
  • have a body mass index (BMI) between 18 and 35 kg/m\^2,
  • and are eligible for laparoscopically-assisted colectomy for primary tumor resection.
  • Patients must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • \- A history of allergic-type reactions to celecoxib or sulphonamides,
  • a history of asthma, skin reactions or other allergic reactions to aspirin or other NSAIDs,
  • a history of thromboembolic event (cerebrovascular accident, transient ischemic attack,
  • unstable angina, myocardial infarction, deep vein thrombosis, or pulmonary embolism),
  • renal insufficiency (defined by a serum creatinine level \> 1.5 mg/dL or blood urea nitrogen level \> 22 mg/dL),
  • active gastrointestinal bleeding in the 60 days before surgery,
  • alcohol or drug abuse, and
  • previous chemotherapy or abdominal/pelvic radiation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Anthony Doufas, MD, PhD
Organization
Stanford University
agdoufas@stanford.edu
1-650-498-7699

Study Officials

  • Anthony Doufas

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 27, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 16, 2018

Results First Posted

December 8, 2016

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)