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Gemcitabine in Treating Patients With Advanced Colorectal Cancer

Phase 2
Completed
Conditions
Colorectal Cancer
Registration Number
NCT00007943
Lead Sponsor
Wake Forest University Health Sciences
Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

🇺🇸

Winston-Salem, North Carolina, United States

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