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

Phase 2

Terminated

• Conditions: Colorectal Neoplasms; Diarrhea

• Registration Number: NCT00040391
• Lead Sponsor: Celgene Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-06-26
• Study First Submitted QC: 2002-06-26
• Study First Posted: 2002-06-27
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Research Center; 🇺🇸 Milwaukee, Wisconsin, United States