Gemcitabine in Treating Patients With Advanced Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00007943|
Recruitment Status : Completed
First Posted : April 13, 2004
Last Update Posted : April 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: gemcitabine hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Official Title:||A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer|
|Actual Study Start Date :||September 2000|
|Actual Primary Completion Date :||February 27, 2001|
|Actual Study Completion Date :||February 27, 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|