Clinical trial NCT00040391: A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Diarrhea
Keywords: Pharmacia
Lead sponsor: Celgene Corporation
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2002-06-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria:

* Age 18 years or older
* Diagnosis of colorectal cancer or adenocarcinoma of the appendix
* A tumor mass that can be measured
* Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1
* Willingness and ability to comply with scheduled visits, treatment plan, and laboratory tests, and other study procedures

Exclusion Criteria:

* Women that are pregnant or lactating
* Prior treatment with Irinotecan
* Partial or complete bowel obstruction, known chronic malabsorption, or total colectomy or other major abdominal surgery that might result in substantial alteration in transit or absorption of oral medication
* Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization
* Current enrollment in another clinical trial
* Administration of any prior systemic anticancer therapy for metastatic colorectal cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Center
state: Arkansas
city: Anaheim
country: United States
facility: Research Center
state: California
city: Concord
country: United States
facility: Research Center
state: California
city: Gilroy
country: United States
facility: Research Center
state: California
city: Los Angeles
country: United States
facility: Research Center
state: California
city: Jacksonville
country: United States
facility: Research Center
state: Florida
city: New Port Richey
country: United States
facility: Research Center
state: Florida
city: New Orleans
country: United States
facility: Research Center
state: Louisiana
city: Scarborough
country: United States
facility: Research Center
state: Maine
city: Pittsfield
country: United States
facility: Research Center
state: Massachusetts
city: East Lansing
country: United States
facility: Research Center
state: Michigan
city: St. Joseph
country: United States
facility: Research Center
state: Michigan
city: Minneapolis
country: United States
facility: Research Center
state: Minnesota
city: St. Joseph
country: United States
facility: Research Center
state: Missouri
city: Las Vegas
country: United States
facility: Research Center
state: Nevada
city: East Setauket
country: United States
facility: Research Center
state: New York
city: Northport
country: United States
facility: Research Center
state: New York
city: Burlington
country: United States
facility: Research Center
state: North Carolina
city: Greenville
country: United States
facility: Research Center
state: North Carolina
city: Zanesville
country: United States
facility: Research Center
state: Ohio
city: Lancaster
country: United States
facility: Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Center
state: Pennsylvania
city: Charleston
country: United States
facility: Research Center
state: South Carolina
city: Charleston
country: United States
facility: Research Center
state: South Carolina
city: Germantown
country: United States
facility: Research Center
state: Tennessee
city: Dallas
country: United States
facility: Research Center
state: Texas
city: Madison
country: United States
facility: Research Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Center
state: Wisconsin
Study officials:
References:
citation: Pan CX, Loehrer P, Seitz D, Helft P, Juliar B, Ansari R, Pletcher W, Vinson J, Cheng L, Sweeney C. A phase II trial of irinotecan, 5-fluorouracil and leucovorin combined with celecoxib and glutamine as first-line therapy for advanced colorectal cancer. Oncology. 2005;69(1):63-70. doi: 10.1159/000087302. Epub 2005 Aug 2.