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

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Pfizer
Study ID
NCT00037180
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Celecoxib — DRUG
  • Irinotecan — DRUG
  • 5-fluorouracil — DRUG
  • Leucovorin — DRUG

Study Details

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.

Key Dates

Start date
Apr 30, 2002
Status verified
Sep 2008
Completion
Jan 31, 2003

Study Design

Enrollment
212 participants
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy

Locations (12)

FacilityCityStateZIPSite coordinators
Pfizer Investigational SiteMobileAlabama36685-
Pfizer Investigational SiteFort LauderdaleFlorida33308-
Pfizer Investigational SitePort Saint LucieFlorida34952-
Pfizer Investigational SiteChicagoIllinois60631-
Pfizer Investigational SiteSaint JosephMissouri64507-
Pfizer Investigational SiteSt LouisMissouri63136-
Pfizer Investigational SiteBuffaloNew York14215-
Pfizer Investigational SiteWilliamsvilleNew York14221-
Pfizer Investigational SiteAltoonaPennsylvania16601-
Pfizer Investigational SitePuyallupWashington98372-
Pfizer Investigational SiteYakimaWashington98902-
Pfizer Investigational SiteMilwaukeeWisconsin53215-

Find similar trials in Mobile, AL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Pfizer Investigational Site· Mobile, ALPfizer Investigational Site· Fort Lauderdale, FLPfizer Investigational Site· Port Saint Lucie, FLPfizer Investigational Site· Chicago, ILPfizer Investigational Site· Saint Joseph, MOPfizer Investigational Site· St Louis, MO

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