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
1 other identifier
interventional
212
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2002
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 16, 2002
CompletedFirst Posted
Study publicly available on registry
May 17, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2003
CompletedSeptember 29, 2008
September 1, 2008
May 16, 2002
September 25, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy
Secondary Outcomes (17)
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.
- +12 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (12)
Pfizer Investigational Site
Mobile, Alabama, 36685, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308, United States
Pfizer Investigational Site
Port Saint Lucie, Florida, 34952, United States
Pfizer Investigational Site
Chicago, Illinois, 60631, United States
Pfizer Investigational Site
Saint Joseph, Missouri, 64507, United States
Pfizer Investigational Site
St Louis, Missouri, 63136, United States
Pfizer Investigational Site
Buffalo, New York, 14215, United States
Pfizer Investigational Site
Williamsville, New York, 14221, United States
Pfizer Investigational Site
Altoona, Pennsylvania, 16601, United States
Pfizer Investigational Site
Puyallup, Washington, 98372, United States
Pfizer Investigational Site
Yakima, Washington, 98902, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, 53215, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 16, 2002
First Posted
May 17, 2002
Study Start
April 1, 2002
Study Completion
January 1, 2003
Last Updated
September 29, 2008
Record last verified: 2008-09