Protocol For Assessment Of Capecitabine For Advanced Colorectal Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years)
Protocol For Assessment Of Capecitabine For Advanced Colorectal Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years)
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 capecitabine in treating older patients who have metastatic or recurrent colorectal cancer that cannot be surgically removed.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs 18 to 59).
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 80 patients (60 patients aged 70 and over, 20 patients aged 18 to 59) will be accrued for this study.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Tucson, Arizona 85724, United States
Little Rock, Arkansas 72205, United States
Orange, California 92868, United States
Aurora, Colorado 80010, United States
Maywood, Illinois 60153-5500, United States
Kansas City, Kansas 66160-7353, United States
Lexington, Kentucky 40536-0084, United States
New Orleans, Louisiana 70112, United States
Shreveport, Louisiana 71130-3932, United States
Southfield, Michigan 48075, United States
New York, New York 10032, United States
Rochester, New York 14642, United States
Charleston, South Carolina 29425, United States
Memphis, Tennessee 38104, United States
San Antonio, Texas 78229-3900, United States