S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer
NCT ID: NCT00107276
Last Updated: 2013-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2005-08-31
2009-08-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with capecitabine works in treating women with stage IV breast cancer.
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Detailed Description
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* Determine the response rate (complete and partial, confirmed and unconfirmed) in women with stage IV breast cancer treated with oral cyclophosphamide and oral capecitabine.
* Determine the progression-free survival and overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral cyclophosphamide once daily on days 1-14 and oral capecitabine twice daily on days 8-21. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then at weeks 7, 13, 19, and 25.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study within 4 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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cyclophosphamide and capecitabine
cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
capecitabine
cyclophosphamide
Interventions
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capecitabine
cyclophosphamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed stage IV breast cancer
* Metastatic disease (M1) OR multiple sites of new disease that is clinically obvious metastatic disease (i.e., multiple sites of new osseous disease)
* Meets 1 of the following criteria:
* Measurable disease
* Non-measurable disease
* MUC-1 antigen level \> 2 times upper limit of normal AND level has increased by 1.5 times
* Must have documented MUC-1 antigen level
* Either cancer antigen (CA) 15-3 or CA 27-29 allowed
* Must have received at least 1 prior hormonal therapy for metastatic disease (estogen receptor-positive patients only)
* No symptomatic brain or CNS metastases
* Previously treated brain or CNS metastasis allowed provided radiotherapy was completed ≥ 8 weeks before study entry
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* No known existing uncontrolled coagulopathy
Hepatic
* Not specified
Renal
* Creatinine clearance \> 40 mL/min
Cardiovascular
* No congestive heart failure
* No symptomatic coronary artery disease
* No cardiac arrhythmia not well controlled with medication
* No myocardial infarction within the past 12 months
* No other clinically significant cardiac disease
Gastrointestinal
* Able to take oral medication
* No uncontrolled nausea, vomiting, or diarrhea
* No lack of physical integrity of the upper gastrointestinal tract
* No malabsorption syndrome
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active infection requiring systemic therapy
* No prior severe reaction to fluoropyrimidines
* No known sensitivity to fluorouracil
* No known dihydropyrimidine dehydrogenase deficiency
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy or biologic therapy for breast cancer
* No concurrent gene therapy for breast cancer
* No concurrent filgrastim (G-CSF)
Chemotherapy
* At least 14 days since prior chemotherapy and recovered
* No more than 2 prior chemotherapy regimens for metastatic disease
* No prior capecitabine for metastatic disease
* No prior oral cyclophosphamide for metastatic disease
* Prior IV cyclophosphamide allowed
* No other concurrent chemotherapy for breast cancer
Endocrine therapy
* See Disease Characteristics
* No concurrent hormonal therapy for breast cancer
Radiotherapy
* See Disease Characteristics
* At least 14 days since prior radiotherapy to non-CNS disease sites and recovered
* No concurrent radiotherapy for breast cancer
Surgery
* Not specified
Other
* Concurrent bisphosphonates allowed
* No concurrent full-dose warfarin
* Concurrent prophylactic warfarin (≤ 1 mg/day) to maintain port patency allowed
* No other concurrent antineoplastic therapy for breast cancer
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Anne F. Schott, MD
Role: STUDY_CHAIR
University of Michigan Rogel Cancer Center
Kathy S. Albain, MD
Role: STUDY_CHAIR
Loyola University
Locations
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Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States
Providence Cancer Center
Anchorage, Alaska, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Eden Medical Center
Castro Valley, California, United States
Kaiser Permanente - Fremont
Fremont, California, United States
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States
Saint Rose Hospital
Hayward, California, United States
Highland General Hospital
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States
Valley Care Medical Center
Pleasanton, California, United States
Kaiser Permanente Medical Center - Redwood City
Redwood City, California, United States
Kaiser Permanente Medical Center - Richmond
Richmond, California, United States
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
South Sacramento Kaiser-Permanente Medical Center
Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Teresa
San Jose, California, United States
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States
Kaiser Foundation Hospital - San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States
Kaiser Permanente Medical Facility - Stockton
Stockton, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
Shaw Cancer Center at Vail Valley Medical Center
Edwards, Colorado, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Edward Hospital Cancer Center
Naperville, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Caritas Holy Family Hospital
Methuen, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
Mount Clemens, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States
Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
St. James Healthcare Cancer Care
Butte, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, United States
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Adirondack Cancer Care - Glens Falls
Glens Falls, New York, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States
MedCentral - Mansfield Hospital
Mansfield, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, United States
Center for Cancer Medicine and Blood Disorders, PA
El Paso, Texas, United States
American Fork Hospital
American Fork, Utah, United States
Sandra L. Maxwell Cancer Center
Cedar City, Utah, United States
Logan Regional Hospital
Logan, Utah, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Latter Day Saints Hospital
Salt Lake City, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, United States
Auburn Regional Center for Cancer Care
Auburn, Washington, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
Olympic Hematology and Oncology
Bremerton, Washington, United States
Providence Centralia Hospital
Centralia, Washington, United States
St. Francis Hospital
Federal Way, Washington, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States
Good Samaritan Cancer Center
Puyallup, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical, PLLC
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Polyclinic First Hill
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
St. Joseph Medical Center at Franciscan Health System
Tacoma, Washington, United States
Allenmore Hospital
Tacoma, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States
St. Clare Hospital
Tacoma, Washington, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
United Hospital Center
Clarksburg, West Virginia, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Countries
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Other Identifiers
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S0430
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000423180
Identifier Type: -
Identifier Source: org_study_id
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