A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
Public ClinicalTrials.gov record NCT00040391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Randomized, Open-label, Controlled, Dose-elevation, Multicenter Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will combine a new investigational drug with standard anti-cancer drugs for the treatment of advanced colorectal cancer. The standard and approved treatment for colorectal cancer is to undergo chemotherapy with a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5-FU), and leucovorin (also known as LV). This is known as the triple therapy. One of the major side effects of CPT-11/5-FU/LV chemotherapy treatment is diarrhea. The purpose of this research study is to see whether adding this investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. This study will also determine if adding the investigational drug to triple therapy has a positive effect on tumors.
Study identification
- NCT ID
- NCT00040391
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2002 (Type not available)
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Dec 1, 2016
Started 2002
United States locations
- U.S. sites
- 28
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Center | Little Rock | Arkansas | 72205 | — |
| Research Center | Anaheim | California | 92801 | — |
| Research Center | Concord | California | 94520 | — |
| Research Center | Gilroy | California | 95020 | — |
| Research Center | Los Angeles | California | 90057 | — |
| Research Center | Jacksonville | Florida | 32207 | — |
| Research Center | New Port Richey | Florida | 34652 | — |
| Research Center | New Orleans | Louisiana | 70115 | — |
| Research Center | Scarborough | Maine | 04074-9308 | — |
| Research Center | Pittsfield | Massachusetts | 01201 | — |
| Research Center | East Lansing | Michigan | 48824 | — |
| Research Center | Saint Joseph | Michigan | 49085 | — |
| Research Center | Minneapolis | Minnesota | 55455 | — |
| Research Center | Saint Joseph | Missouri | 64507 | — |
| Research Center | Las Vegas | Nevada | 89106 | — |
| Research Center | East Setauket | New York | 11733 | — |
| Research Center | Northport | New York | 11768-2364 | — |
| Research Center | Burlington | North Carolina | 27216 | — |
| Research Center | Greenville | North Carolina | 27834 | — |
| Research Center | Zanesville | Ohio | 43701 | — |
| Research Center | Lancaster | Pennsylvania | 17605 | — |
| Research Center | Philadelphia | Pennsylvania | 19140-5189 | — |
| Research Center | Charleston | South Carolina | 29403 | — |
| Research Center | Charleston | South Carolina | 29406 | — |
| Research Center | Germantown | Tennessee | 38138 | — |
| Research Center | Dallas | Texas | 75230 | — |
| Research Center | Madison | Wisconsin | 53792-2454 | — |
| Research Center | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00040391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 1, 2016 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00040391 live on ClinicalTrials.gov.