Colorectal Neoplasms, Diarrhea
Conditions
Keywords
Pharmacia
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.
Interventions
Sponsors
Pfizer
Celgene Corporation
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed