Gemcitabine in Treating Patients With Advanced Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have advanced colorectal cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer|
|Actual Study Start Date:||September 2000|
|Study Completion Date:||February 27, 2001|
|Primary Completion Date:||February 27, 2001 (Final data collection date for primary outcome measure)|
- Determine the response rate in patients with advanced colorectal cancer treated with gemcitabine.
- Determine the toxic effects of this drug in these patients.
- Determine the progression-free survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV continuously over 24 hours on days 1, 8, and 15. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 12-41 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007943
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157-1082|
|Study Chair:||Paul D. Savage, MD||Wake Forest University Health Sciences|