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Trial record 1 of 1 for:    NCT00037180
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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
Information provided by:

Tracking Information
First Submitted Date  ICMJE May 16, 2002
First Posted Date  ICMJE May 17, 2002
Last Update Posted Date September 29, 2008
Study Start Date  ICMJE April 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2006)
Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00037180 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2006)
  • Severity of all grades of diarrhea, overall and by cycle
  • Duration of diarrhea, by cycle
  • Diarrhea grade, by day, by cycle
  • Stool count, by day, by cycle
  • Severity of asthenia (fatigue), by week.
  • Asthenia will be assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
  • Duration of asthenia, by week, as measured by the FACIT-Fatigue scale
  • 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
  • Compliance with celecoxib use Incidence, quantity, and duration of loperamide use
  • Tumor response rate (overall and confirmed)using the World Health Organization [WHO] Response Evaluation Criteria in Solid Tumors [RECIST 2000]
  • Serum tumor marker (carcinoembryonic antigen [CEA]) response rate (as characterized by a 50% reduction from baseline)
  • Time to tumor progression (TTP)
  • Time to treatment failure (TTF)
  • Survival Post-study anticancer treatment
  • 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)
  • Inflammatory cytokines which may serve as biomarkers for cancer-related outcomes Beta-glucuronidase as a potential biomarker for tumor response
  • Health resource utilization (collected data to be evaluated separately from this protocol)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasm Metastasis
  • Colorectal Neoplasms
Intervention  ICMJE
  • Drug: Celecoxib
  • Drug: Irinotecan
  • Drug: 5-fluorouracil
  • Drug: Leucovorin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: August 23, 2006)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00037180
Other Study ID Numbers  ICMJE IQ8-01-02-016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer Call Center Pfizer
PRS Account Pfizer
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP