We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00258232
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : April 8, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Brief Summary:

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving celecoxib together with capecitabine and irinotecan may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving celecoxib together with capecitabine and irinotecan works in treating patients with recurrent or metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: capecitabine Drug: celecoxib Drug: irinotecan hydrochloride Phase 2

Detailed Description:



  • Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with celecoxib, capecitabine, and irinotecan.


  • Determine the time to progression in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the time to treatment failure in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral celecoxib twice daily on days -7 to 21 during course 1 and on days 1-21 in all subsequent courses. Patients also receive oral capecitabine twice daily on days 1-14 and irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response after 4 courses may temporarily discontinue treatment for no more than 4 weeks.

After completion of study treatment, patients are followed every 6 months for survival.

PROJECTED ACCRUAL: A total of 21-44 patients will be accrued for this study within 7-18 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer
Study Start Date : January 2002
Actual Primary Completion Date : March 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Response rate by RECIST criteria at every other course

Secondary Outcome Measures :
  1. Time to progression
  2. Toxicity
  3. Overall survival
  4. Time to treatment failure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the colon or rectum

    • Locally recurrent or metastatic disease
  • Measurable disease, defined as ≥ 1 measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan

    • Bone metastases, ascites, and pleural effusion are not considered measurable disease
    • Measurable lesions must be located outside a previously irradiated field


Performance status

  • SWOG 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin normal
  • No Gilbert's disease


  • Creatinine clearance > 50 mL/min


  • No clinically significant cardiac disease that is not well controlled by medication, including any of the following conditions:

    • Congestive heart failure
    • Symptomatic coronary artery disease
    • Cardiac arrhythmias
  • No myocardial infarction within the past year


  • Must have a physically intact upper gastrointestinal tract
  • Able to swallow tablets
  • No history of peptic ulcer disease or gastroesophageal reflux
  • No malabsorption syndrome


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known HIV positivity
  • No asthma, urticaria, or allergic-type reaction after prior treatment with aspirin or other nonsteroidal anti-inflammatory drugs
  • No other malignancy except curatively treated cancer with no evidence of active disease
  • No unresolved bacterial infection requiring antibiotics
  • No other serious infection
  • No known allergy to study drugs or sulfa drugs


Biologic therapy

  • Not specified


  • No prior chemotherapy for colorectal cancer

    • Patients relapsing > 6 months after completion of prior adjuvant chemotherapy allowed
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy
  • No concurrent anticancer radiotherapy


  • Recovered from prior surgery
  • No concurrent anticancer surgery


  • Prior celecoxib for nonmalignant disorders allowed
  • No other concurrent cyclooxygenase-2 inhibitors or nonsteroidal anti-inflammatory drugs, including any of the following:

    • Rofecoxib
    • Ibuprofen
    • Naproxen
    • Etodolac
    • Oxaprozin
    • Diflunisal
    • Nabumetone
    • Tolmetin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258232

Layout table for location information
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0944
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Philip A. Philip, MD, PhD, FRCP Barbara Ann Karmanos Cancer Institute
Publications of Results:
El-Rayes BF, Venkat R, Heilbrun LK: A dose attenuated schedule of irinotecan and capecitabine in combination with celecoxib in advanced colorectal cancer. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-254, 2006.

Layout table for additonal information
Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00258232    
Other Study ID Numbers: CDR0000445439
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013
Keywords provided by Barbara Ann Karmanos Cancer Institute:
adenocarcinoma of the colon
adenocarcinoma of the rectum
recurrent colon cancer
recurrent rectal cancer
stage IV colon cancer
stage IV rectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors