Back to resultsA Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
Primary Purpose
Colorectal Neoplasms, Diarrhea
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Investigational drug
Irinotecan
5-fluorouracil
Leucovorin
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Pharmacia
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
Sites / Locations
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Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00040391
First Posted
June 26, 2002
Last Updated
November 30, 2016
Sponsor
Celgene Corporation
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00040391
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene Corporation
Collaborators
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Diarrhea
Keywords
Pharmacia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Investigational drug
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Type
Drug
Intervention Name(s)
Leucovorin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Research Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Research Center
City
Gilroy
State/Province
California
ZIP/Postal Code
95020
Country
United States
Facility Name
Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Research Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Research Center
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Research Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Research Center
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-9308
Country
United States
Facility Name
Research Center
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Research Center
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Research Center
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Research Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Research Center
City
St. Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Research Center
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Research Center
City
Northport
State/Province
New York
ZIP/Postal Code
11768-2364
Country
United States
Facility Name
Research Center
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27216
Country
United States
Facility Name
Research Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Research Center
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Research Center
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17605
Country
United States
Facility Name
Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140-5189
Country
United States
Facility Name
Research Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Research Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Research Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Research Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-2454
Country
United States
Facility Name
Research Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16088234
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.
Results Reference
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Learn more about this trial
A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
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