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

This study has been terminated.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00037180
First received: May 16, 2002
Last updated: September 25, 2008
Last verified: September 2008

May 16, 2002
September 25, 2008
April 2002
Not Provided
Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy
Not Provided
Complete list of historical versions of study NCT00037180 on ClinicalTrials.gov Archive Site
  • 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)
Not Provided
Not Provided
Not Provided
 
For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Neoplasm Metastasis
  • Colorectal Neoplasms
  • Drug: Celecoxib
  • Drug: Irinotecan
  • Drug: 5-fluorouracil
  • Drug: Leucovorin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
212
January 2003
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00037180
IQ8-01-02-016
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2008

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