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For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy

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. Identifier: NCT00037180
Recruitment Status : Terminated
First Posted : May 17, 2002
Last Update Posted : September 29, 2008
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Brief Summary:
The Diarrhea Prevention with an investigational drug trial, will evaluate whether adding an investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. The standard and approved treatment for patients with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5FU), and leucovorin (also known as LV). Preclinical data from animal models suggest that the investigational drug may offer an effective means for preventing CPT-11/5FU/LV-induced diarrhea. It is also hypothesized that the investigational drug-mediated anti-angiogenesis could induce a favorable tumor response.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Colorectal Neoplasms Drug: Celecoxib Drug: Irinotecan Drug: 5-fluorouracil Drug: Leucovorin Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Double-Blind, Multicenter Trial Of Celecoxib Vs Placebo For The Prevention Of Diarrhea Associated With CPT-11/5fu/LV Chemotherapy In Patients With Previously Untreated Metastatic Colorectal Cancer
Study Start Date : April 2002
Actual Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Primary Outcome Measures :
  1. Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy

Secondary Outcome Measures :
  1. Severity of all grades of diarrhea, overall and by cycle
  2. Duration of diarrhea, by cycle
  3. Diarrhea grade, by day, by cycle
  4. Stool count, by day, by cycle
  5. Severity of asthenia (fatigue), by week.
  6. Asthenia will be assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
  7. Duration of asthenia, by week, as measured by the FACIT-Fatigue scale
  8. Type, frequency, severity, timing, and relatedness of all adverse events CPT-11/5-FU/LV treatment administration as characterized by median, mean, and range of doses given; dose modifications, omissions, and delays; and actual and relative dose intensity
  9. Compliance with celecoxib use Incidence, quantity, and duration of loperamide use
  10. Tumor response rate (overall and confirmed)using the World Health Organization [WHO] Response Evaluation Criteria in Solid Tumors [RECIST 2000]
  11. Serum tumor marker (carcinoembryonic antigen [CEA]) response rate (as characterized by a 50% reduction from baseline)
  12. Time to tumor progression (TTP)
  13. Time to treatment failure (TTF)
  14. Survival Post-study anticancer treatment
  15. Peak plasma levels and AUC 0-24 values for CPT-11 and its major metabolites, SN-38, SN-38 glucuronide (SN-38G), and aminopentane carboxylic acid (APC)
  16. Inflammatory cytokines which may serve as biomarkers for cancer-related outcomes Beta-glucuronidase as a potential biomarker for tumor response
  17. Health resource utilization (collected data to be evaluated separately from this protocol)

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease and present or past histological documentation of adenocarcinoma of the colon or rectum.
  • Tumor must be measureable.
  • Resolution of all acute toxic effects of any prior radiotherapy or surgical procedure.
  • ECOG performance status 0 or 1. Age >= 18 years.
  • Required baseline laboratory.
  • Negative pregnancy test.
  • Willingness and ability to comply with the treatment plan.

Exclusion Criteria:

  • Current enrollment in another clinical trial.
  • Prior adjuvant therapy for colorectal cancer <= 6 months prior to randomization.
  • Prior systemic anticancer therapy or intra-arterial cytotoxic chemotherapy given as treatment for metastatic colorectal cancer.
  • Known allergy to CPT-11, 5-FU, LV, celecoxib, other COX-2 inhibitors, non-steroidal anti-inflammatory drugs (NSAIDS), salicylates, or sulfonamides.
  • Chronic concomitant use of full-dose aspirin, other NSAIDs or other COX-2 inhibitors for a chronic nonmalignant condition.
  • A requirement for chronic concomitant use of low-dose (cardioprotective) aspirin.
  • Chronic oral steroid use for treatment of a non-malignant condition.
  • Known ulceration of the gastric or duodenal mucosa <= 30 days prior to randomization.
  • Need for concomitant fluconazole or lithium.
  • Any known significant bleeding disorder.
  • Active inflammatory bowel disease or chronic diarrhea.

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 identifier (NCT number): NCT00037180

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United States, Alabama
Pfizer Investigational Site
Mobile, Alabama, United States, 36685
United States, Florida
Pfizer Investigational Site
Ft. Lauderdale, Florida, United States, 33308
Pfizer Investigational Site
Port St. Lucie, Florida, United States, 34952
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60631
United States, Missouri
Pfizer Investigational Site
St. Joseph, Missouri, United States, 64507
Pfizer Investigational Site
St. Louis, Missouri, United States, 63136
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14215
Pfizer Investigational Site
Williamsville, New York, United States, 14221
United States, Pennsylvania
Pfizer Investigational Site
Altoona, Pennsylvania, United States, 16601
United States, Washington
Pfizer Investigational Site
Puyallup, Washington, United States, 98372
Pfizer Investigational Site
Yakima, Washington, United States, 98902
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00037180    
Other Study ID Numbers: IQ8-01-02-016
First Posted: May 17, 2002    Key Record Dates
Last Update Posted: September 29, 2008
Last Verified: September 2008
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs