A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00040391
• Other study ID #: 440E-ONC-0020-315
• Status: Terminated
• Phase: Phase 2
• First received: June 26, 2002
• Last updated: November 30, 2016
• Start date: June 2002

Study information

• Verified date: November 2016
• Source: Celgene Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Diarrhea

Intervention

Drug:
• Investigational drug

• Irinotecan

• 5-fluorouracil

• Leucovorin

Locations

Country	Name	City	State
United States	Research Center	Anaheim	California
United States	Research Center	Burlington	North Carolina
United States	Research Center	Charleston	South Carolina
United States	Research Center	Charleston	South Carolina
United States	Research Center	Concord	California
United States	Research Center	Dallas	Texas
United States	Research Center	East Lansing	Michigan
United States	Research Center	East Setauket	New York
United States	Research Center	Germantown	Tennessee
United States	Research Center	Gilroy	California
United States	Research Center	Greenville	North Carolina
United States	Research Center	Jacksonville	Florida
United States	Research Center	Lancaster	Pennsylvania
United States	Research Center	Las Vegas	Nevada
United States	Research Center	Little Rock	Arkansas
United States	Research Center	Los Angeles	California
United States	Research Center	Madison	Wisconsin
United States	Research Center	Milwaukee	Wisconsin
United States	Research Center	Minneapolis	Minnesota
United States	Research Center	New Orleans	Louisiana
United States	Research Center	New Port Richey	Florida
United States	Research Center	Northport	New York
United States	Research Center	Philadelphia	Pennsylvania
United States	Research Center	Pittsfield	Massachusetts
United States	Research Center	Scarborough	Maine
United States	Research Center	St. Joseph	Michigan
United States	Research Center	St. Joseph	Missouri
United States	Research Center	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Celgene Corporation	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation