A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- Celgene Corporation
- Study ID
- NCT00040391
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Colorectal Neoplasms
- Diarrhea
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Investigational drug — DRUG
- Irinotecan — DRUG
- 5-fluorouracil — DRUG
- Leucovorin — DRUG
Study Details
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.
Key Dates
- Start date
- Jun 30, 2002
- Status verified
- Nov 2016
Study Design
- Primary purpose
- TREATMENT
Locations (28)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| 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 | - |
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