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)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
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)
OBJECTIVES:
- Determine the feasibility of enrolling patients aged 70 and over with unresectable
metastatic or recurrent colorectal cancer to a structured phase II study.
- Determine the anticancer efficacy of capecitabine, in terms of objective response rate
(confirmed and unconfirmed, complete and partial responses) and 2-year survival, in
these patients.
- Determine the toxicity and tolerability of this drug in these patients.
- Determine the feasibility of using standardized self-report measures of comorbidity,
depression, and functional status of patients treated with this drug.
- Determine the clinical pharmacology of this drug in these patients.
- Determine whether patients under 60 years of age treated with this drug have clinical
pharmacologic parameters similar to those reported in the literature.
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic or recurrent colorectal cancer
not amenable to surgical resection
- Measurable disease
- No known brain metastases by MRI or CT scan
PATIENT CHARACTERISTICS:
Age
- 70 and over OR
- 18 to 59
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate
transaminase) no greater than 2 times ULN
Renal
- Creatinine no greater than 2 times ULN
- Creatinine clearance greater than 50 mL/min
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No known seizure disorder
- No other malignancy except adequately treated basal cell or squamous cell skin
cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer
currently in complete remission, or any other cancer for which the patient has been
disease free for 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for advanced cancer
- Prior adjuvant chemotherapy allowed provided recurrence occurred more than 1 year
after the last treatment
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 4 weeks since prior sorivudine or brivudine
- No concurrent sorivudine or brivudine
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling
Outcome Time Frame:
Registration
Safety Issue:
No
Principal Investigator
Heinz-Josef Lenz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
USC/Norris Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000258049
NCT ID:
NCT00049335
Start Date:
February 2003
Completion Date:
June 2007
Related Keywords:
- Colorectal Cancer
- recurrent colon cancer
- stage IV colon cancer
- recurrent rectal cancer
- stage IV rectal cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| Harrington Cancer Center | Amarillo, Texas 79106 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange, California 92868 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix, Arizona 85012 |
| Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
| Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
| Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
| Puget Sound Oncology Consortium | Seattle, Washington 98109 |
| Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Veterans Affairs Medical Center - Amarillo | Amarillo, Texas 79106 |
| CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
| Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
| St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
| Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
| Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
| Veterans Affairs Medical Center - Little Rock | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Loma Linda (Pettis) | Loma Linda, California 92357 |
| Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
| Josephine Ford Cancer Center at Henry Ford Health System | Detroit, Michigan 48202 |
| Providence Cancer Institute at Providence Hospital - Southfield | Southfield, Michigan 48075 |
| University of Tennessee Cancer Institute at Methodist Central Hospital | Memphis, Tennessee 38104 |
