ClinicalTrials.gov record
Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.
ClinicalTrials.gov ID: NCT00101686
Public ClinicalTrials.gov record NCT00101686. 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 Randomized, Multi-Center Phase III Trial Of Irinotecan In Combination With Three Different Methods Of Administration Of Fluoropyrimidine: Infusional 5-FU (FOLFIRI), Modified-Bolus 5-FU (Day 1 & 8), And Oral Capecitabine (Day 1-14); With Celecoxib Versus Placebo As First-Line Treatment For Patients With Metastatic Colorectal Cancer Study Amended April 23, 2004 To Include Bevacizumab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI \[a chemotherapy regime that combines bolus irinotecan and leucovorin \[LV\] with infusional 5-fluorouracil (5-FU)\] + bevacizumab and mlFL + bevacizumab. Measures of efficacy and safety will be reported.
Study identification
- NCT ID
- NCT00101686
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 547 participants
Conditions and interventions
Conditions
Interventions
- Modified Bolus 5-FU/LV with Irinotecan Drug
- FOLFIRI + bevacizumab Drug
- miFL + bevacizumab Drug
- Infusional 5-FU/LV with Irinotecan Drug
- Oral Capecitabine with Irinotecan Drug
Drug
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
- Feb 2003 (Type not available)
- Primary completion
- Oct 2008 (Actual)
- Completion
- Oct 2008 (Actual)
- Last update posted
- Jan 12, 2010
2003 – 2008
United States locations
- U.S. sites
- 141
- U.S. states
- 37
- U.S. cities
- 126
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pfizer Investigational Site | Birmgingham | Alabama | 35205 | — |
| Pfizer Investigational Site | Birmingham | Alabama | 35205 | — |
| Pfizer Investigational Site | Birmngham | Alabama | 35211 | — |
| Pfizer Investigational Site | Mobile | Alabama | 36608 | — |
| Pfizer Investigational Site | Flagstaff | Arizona | 86001 | — |
| Pfizer Investigational Site | Sedona | Arizona | 86336 | — |
| Pfizer Investigational Site | Tucson | Arizona | 85712 | — |
| Pfizer Investigational Site | Hot Spring | Arkansas | 71913 | — |
| Pfizer Investigational Site | Springdale | Arkansas | 72764 | — |
| Pfizer Investigational Site | Arroyo Grande | California | 93420 | — |
| Pfizer Investigational Site | Fountian Valley | California | 92708 | — |
| Pfizer Investigational Site | Fresno | California | 93710 | — |
| Pfizer Investigational Site | Los Gatos | California | 95032 | — |
| Pfizer Investigational Site | Mission Hills | California | 91345 | — |
| Pfizer Investigational Site | Modesto | California | 95355 | — |
| Pfizer Investigational Site | Orange | California | 92868 | — |
| Pfizer Investigational Site | Oxnard | California | 93030 | — |
| Pfizer Investigational Site | San Diego | California | 92123 | — |
| Pfizer Investigational Site | San Jose | California | 95125 | — |
| Pfizer Investigational Site | Boulder | Colorado | 80304 | — |
| Pfizer Investigational Site | Norwalk | Connecticut | 06581 | — |
| Pfizer Investigational Site | Stamford | Connecticut | 06902-3628 | — |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| Pfizer Investigational Site | Altamonte Springs | Florida | 32701 | — |
| Pfizer Investigational Site | Hollywood | Florida | 33021 | — |
| Pfizer Investigational Site | Lauderhill | Florida | 33319 | — |
| Pfizer Investigational Site | Miami | Florida | 33133 | — |
| Pfizer Investigational Site | Miami Beach | Florida | — | — |
| Pfizer Investigational Site | New Port Richey | Florida | 34652 | — |
| Pfizer Investigational Site | Ocala | Florida | 34474 | — |
| Pfizer Investigational Site | Sarasota | Florida | 34239 | — |
| Pfizer Investigational Site | Tamarac | Florida | 33321 | — |
| Pfizer Investigational Site | Macon | Georgia | 31201 | — |
| Pfizer Investigational Site | Niles | Illinois | 60714 | — |
| Pfizer Investigational Site | Rockford | Illinois | 61108-2472 | — |
| Pfizer Investigational Site | Skokie | Illinois | 60077 | — |
| Pfizer Investigational Site | Fishers | Indiana | 46038 | — |
| Pfizer Investigational Site | Fort Wayne | Indiana | 46815 | — |
| Pfizer Investigational Site | Terre Haute | Indiana | 47802 | — |
| Pfizer Investigational Site | Overland Park | Kansas | 66210 | — |
| Pfizer Investigational Site | Alexandria | Louisiana | 71301 | — |
| Pfizer Investigational Site | Shrevport | Louisiana | 71101 | — |
| Pfizer Investigational Site | Bangor | Maine | 04401 | — |
| Pfizer Investigational Site | Annapolis | Maryland | 21401 | — |
| Pfizer Investigational Site | Boston | Massachusetts | 02114 | — |
| Pfizer Investigational Site | Boston | Massachusetts | 02115 | — |
| Pfizer Investigational Site | Boston | Massachusetts | 02215 | — |
| Pfizer Investigational Site | Burlington | Massachusetts | 01805 | — |
| Pfizer Investigational Site | Pittsfield | Massachusetts | 01201 | — |
| Pfizer Investigational Site | Grand Rapids | Michigan | 49603 | — |
| Pfizer Investigational Site | Burnsville | Minnesota | 55337 | — |
| Pfizer Investigational Site | Robbinsdale | Minnesota | 55422 | — |
| Pfizer Investigational Site | Columbia | Missouri | 65201 | — |
| Pfizer Investigational Site | Columbia | Missouri | 65203 | — |
| Pfizer Investigational Site | Joplin | Missouri | 64804 | — |
| Pfizer Investigational Site | St Louis | Missouri | 63136 | — |
| Pfizer Investigational Site | St Louis | Missouri | 63141 | — |
| Pfizer Investigational Site | Billings | Montana | 59101 | — |
| Pfizer Investigational Site | Omaha | Nebraska | 68131 | — |
| Pfizer Investigational Site | Las Vegas | Nevada | 89109 | — |
| Pfizer Investigational Site | Hooksett | New Hampshire | 03106 | — |
| Pfizer Investigational Site | Lebanon | New Hampshire | 03756-0001 | — |
| Pfizer Investigational Site | Nashua | New Hampshire | 03060 | — |
| Pfizer Investigational Site | Summit | New Jersey | 07901 | — |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87109 | — |
| Pfizer Investigational Site | Farmington | New Mexico | 87401 | — |
| Pfizer Investigational Site | Santa Fe | New Mexico | 87501 | — |
| Pfizer Investigational Site | Albany | New York | 12208 | — |
| Pfizer Investigational Site | Manhaset | New York | 11030 | — |
| Pfizer Investigational Site | Rockville Centre | New York | 11570 | — |
| Pfizer Investigational Site | Asheville | North Carolina | 28801 | — |
| Pfizer Investigational Site | Cary | North Carolina | 27511 | — |
| Pfizer Investigational Site | Fayetteville | North Carolina | 28302-2000 | — |
| Pfizer Investigational Site | Greensboro | North Carolina | 27403 | — |
| Pfizer Investigational Site | Hendersonville | North Carolina | 28791 | — |
| Pfizer Investigational Site | Hickory | North Carolina | 28602 | — |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27157 | — |
| Pfizer Investigational Site | Columbus | Ohio | 43215 | — |
| Pfizer Investigational Site | Dayton | Ohio | 45409 | — |
| Pfizer Investigational Site | Bartlesville | Oklahoma | 74006 | — |
| Pfizer Investigational Site | Norman | Oklahoma | 73071 | — |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73104 | — |
| Pfizer Investigational Site | Eugene | Oregon | 97401 | — |
| Pfizer Investigational Site | Portland | Oregon | 97213 | — |
| Pfizer Investigational Site | Abington | Pennsylvania | 19001 | — |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19014-4283 | — |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19141 | — |
| Pfizer Investigational Site | Reading | Pennsylvania | 19603 | — |
| Pfizer Investigational Site | Chattanooga | Tennessee | 37404 | — |
| Pfizer Investigational Site | Collierville | Tennessee | 38017 | — |
| Pfizer Investigational Site | Germantown | Tennessee | 38138 | — |
| Pfizer Investigational Site | Jackson | Tennessee | 38301 | — |
| Pfizer Investigational Site | Knoxville | Tennessee | 37916 | — |
| Pfizer Investigational Site | Knoxville | Tennessee | 37920 | — |
| Pfizer Investigational Site | Abilene | Texas | 79606-5208 | — |
| Pfizer Investigational Site | Arlington | Texas | 76012 | — |
| Pfizer Investigational Site | Austin | Texas | 78705 | — |
| Pfizer Investigational Site | Austin | Texas | 78731 | — |
| Pfizer Investigational Site | Beaumont | Texas | 77702-1449 | — |
| Pfizer Investigational Site | Bedford | Texas | 76022 | — |
| Pfizer Investigational Site | Dallas | Texas | 75230-2510 | — |
| Pfizer Investigational Site | Dallas | Texas | 75231-4400 | — |
| Pfizer Investigational Site | Dallas | Texas | 75237 | — |
| Pfizer Investigational Site | Dallas | Texas | 75246 | — |
| Pfizer Investigational Site | Denton | Texas | 76210 | — |
| Pfizer Investigational Site | El Paso | Texas | 79902 | — |
| Pfizer Investigational Site | El Paso | Texas | 79915 | — |
| Pfizer Investigational Site | Fort Worth | Texas | 76104 | — |
| Pfizer Investigational Site | Fredericksburg | Texas | 78624-3847 | — |
| Pfizer Investigational Site | Garland | Texas | 75042 | — |
| Pfizer Investigational Site | Houston | Texas | 77030 | — |
| Pfizer Investigational Site | Houston | Texas | 77054 | — |
| Pfizer Investigational Site | Irving | Texas | 75061-224 | — |
| Pfizer Investigational Site | Lewisville | Texas | 75067 | — |
| Pfizer Investigational Site | Longview | Texas | 75601 | — |
| Pfizer Investigational Site | McAllen | Texas | 78503 | — |
| Pfizer Investigational Site | Mesquite | Texas | 75050 | — |
| Pfizer Investigational Site | Midland | Texas | 79701 | — |
| Pfizer Investigational Site | New Braunfels | Texas | 78130 | — |
| Pfizer Investigational Site | Odessa | Texas | 79761 | — |
| Pfizer Investigational Site | Paris | Texas | 75460 | — |
| Pfizer Investigational Site | Sherman | Texas | 75090-0504 | — |
| Pfizer Investigational Site | Temple | Texas | 76508 | — |
| Pfizer Investigational Site | Tyler | Texas | 75701-2001 | — |
| Pfizer Investigational Site | Tyler | Texas | 75702 | — |
| Pfizer Investigational Site | Waco | Texas | 76712 | — |
| Pfizer Investigational Site | Webster | Texas | 77598 | — |
| Pfizer Investigational Site | Wichita Falls | Texas | 76310 | — |
| Pfizer Investigational Site | Colchester | Vermont | 05446 | — |
| Pfizer Investigational Site | Fairfax | Virginia | 22031 | — |
| Pfizer Investigational Site | Newport News | Virginia | 23606 | — |
| Pfizer Investigational Site | Roanoke | Virginia | 24014 | — |
| Pfizer Investigational Site | Edmonds | Washington | 98026 | — |
| Pfizer Investigational Site | Lacy | Washington | 98503 | — |
| Pfizer Investigational Site | Seattle | Washington | 98133 | — |
| Pfizer Investigational Site | Spokane | Washington | 99202 | — |
| Pfizer Investigational Site | Yakima | Washington | 98902 | — |
| Pfizer Investigational Site | Glendale | Wisconsin | 53212 | — |
| Pfizer Investigational Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00101686, 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 Jan 12, 2010 · Synced Oct 26, 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 NCT00101686 live on ClinicalTrials.gov.