S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed
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.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Alabama
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Mobile, Alabama, Forenede Stater, 36607
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006-2726
- CCOP - Western Regional, Arizona
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Phoenix, Arizona, Forenede Stater, 85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson, Arizona, Forenede Stater, 85723
- Veterans Affairs Medical Center - Tucson
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Forenede Stater, 72205
- Veterans Affairs Medical Center - Little Rock
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California
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Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, Forenede Stater, 92357
- Veterans Affairs Medical Center - Loma Linda (Pettis)
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forenede Stater, 90033
- USC/Norris Comprehensive Cancer Center and Hospital
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Martinez, California, Forenede Stater, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Forenede Stater, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
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Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
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Colorado
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Aurora, Colorado, Forenede Stater, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Denver, Colorado, Forenede Stater, 80220
- Veterans Affairs Medical Center - Denver
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20060
- MBCCOP - Howard University Cancer Center
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Florida
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Tampa, Florida, Forenede Stater, 33612
- Veterans Affairs Medical Center - Tampa (Haley)
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342-1701
- CCOP - Atlanta Regional
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- MBCCOP - Hawaii
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Forenede Stater, 60612
- MBCCOP - University of Illinois at Chicago
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Decatur, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
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Hines, Illinois, Forenede Stater, 60141
- Veterans Affairs Medical Center - Hines
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Maywood, Illinois, Forenede Stater, 60153-5500
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160-7353
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Wichita, Kansas, Forenede Stater, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Forenede Stater, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40502-2236
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Forenede Stater, 40536-0084
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Shreveport, Louisiana, Forenede Stater, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Forenede Stater, 71101-4295
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Cancer Research Center at Boston Medical Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, Forenede Stater, 48109-0948
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Forenede Stater, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Detroit, Michigan, Forenede Stater, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids
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Royal Oak, Michigan, Forenede Stater, 48073-6769
- CCOP - Beaumont
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Southfield, Michigan, Forenede Stater, 48075
- Providence Cancer Institute at Providence Hospital - Southfield
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Forenede Stater, 39216
- Veterans Affairs Medical Center - Jackson
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Missouri
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, Forenede Stater, 63110
- St. Louis University Hospital Cancer Center
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Forenede Stater, 87131
- MBCCOP - University of New Mexico HSC
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New York
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New York, New York, Forenede Stater, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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North Carolina
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Goldsboro, North Carolina, Forenede Stater, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, Forenede Stater, 45267-0501
- Charles M. Barrett Cancer Center at University Hospital
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Cleveland, Ohio, Forenede Stater, 44195-9001
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
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Dayton, Ohio, Forenede Stater, 45429
- CCOP - Dayton
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Dayton, Ohio, Forenede Stater, 45428-1002
- Veterans Affairs Medical Center - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma University Medical center
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Oregon
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Portland, Oregon, Forenede Stater, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Forenede Stater, 97201-3098
- Cancer Institute at Oregon Health and Science University
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Charleston, South Carolina, Forenede Stater, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38104
- Veterans Affairs Medical Center - Memphis
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Memphis, Tennessee, Forenede Stater, 38104
- University of Tennessee Cancer Institute at Methodist Central Hospital
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Texas
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Amarillo, Texas, Forenede Stater, 79106
- Harrington Cancer Center
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Amarillo, Texas, Forenede Stater, 79106
- Veterans Affairs Medical Center - Amarillo
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Fort Sam Houston, Texas, Forenede Stater, 78234-6200
- Brooke Army Medical Center
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Galveston, Texas, Forenede Stater, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, Forenede Stater, 77030-4095
- University of Texas - MD Anderson Cancer Center
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San Antonio, Texas, Forenede Stater, 78229-3900
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Forenede Stater, 78229
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Forenede Stater, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Forenede Stater, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Forenede Stater, 84112-5550
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Forenede Stater, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Forenede Stater, 98108
- Veterans Affairs Medical Center - Seattle
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Seattle, Washington, Forenede Stater, 98109
- Puget Sound Oncology Consortium
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Tacoma, Washington, Forenede Stater, 98405-0986
- CCOP - Northwest
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Capecitabine
Capecitabine 1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, Days 1-14 of 21 day cycle.
|
1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, on Days 1-14 of 21 day cycle
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling
Tidsramme: Registration
|
Registration
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Toksicitet
Tidsramme: 3 år
|
3 år
|
|
Efficacy of capecitabine for management of advanced colorectal cancer patients aged 70 years or older based on objective response rate and 2 year survival
Tidsramme: 2 years
|
2 years
|
|
Assess parameters of clinical pharmacology of capecitabine in patients aged 70 years or older including half life value(s), AUC (area under curve) and steady state levels
Tidsramme: 3 years
|
3 years
|
|
Assess whether patients under 60 years have clinical pharmacologic parameters similar to those reported in the literature
Tidsramme: 3 years
|
3 years
|
|
Explore, at a preliminary level, the feasibility of studying genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance to capecitabine
Tidsramme: 3 years
|
3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Capecitabin
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CDR0000258049
- U10CA032102 (U.S. NIH-bevilling/kontrakt)
- S0030 (Anden identifikator: SWOG)
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