S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer
- Registration Number
- NCT00107276
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with capecitabine works in treating women with stage IV breast cancer.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 112
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cyclophosphamide and capecitabine capecitabine cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each cyclophosphamide and capecitabine cyclophosphamide cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
- Primary Outcome Measures
Name Time Method Response Rate (Complete and Partial, Confirmed and Unconfirmed) Patients assessed at least every six weeks while on protocol treatment Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
- Secondary Outcome Measures
Name Time Method Progression-free Survival and Overall Survival two years Progression-Free Survival: From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.
Overall Survival: From date of registration to date of death due to any cause. Patients last known to be alive are censored at last date of contact.
Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.Toxicity Patients assessed after each 21-day cycle for 8 cycles (24 weeks of treatment) Number of patients for whom Grade 3 or higher toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Trial Locations
- Locations (144)
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Kaiser Permanente Medical Center - Redwood City
🇺🇸Redwood City, California, United States
Kaiser Foundation Hospital - San Rafael
🇺🇸San Rafael, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, 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
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
🇺🇸San Francisco, California, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
Kaiser Permanente Medical Center - Hayward
🇺🇸Hayward, California, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Auburn Regional Center for Cancer Care
🇺🇸Auburn, Washington, United States
Providence Centralia Hospital
🇺🇸Centralia, Washington, United States
St. Joseph Medical Center at Franciscan Health System
🇺🇸Tacoma, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
St. Clare Hospital
🇺🇸Tacoma, Washington, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Kaiser Permanente Medical Center - Richmond
🇺🇸Richmond, California, United States
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Sandra L. Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Saint Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mt. Vernon, Washington, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
🇺🇸Parkersburg, West Virginia, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
United Hospital Center
🇺🇸Clarksburg, West Virginia, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente - Fremont
🇺🇸Fremont, 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
Kaiser Permanente Medical Center - Roseville
🇺🇸Roseville, California, United States
Valley Care Medical Center
🇺🇸Pleasanton, 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 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 Center - Walnut Creek
🇺🇸Walnut Creek, California, United States
Kaiser Permanente Medical Facility - Stockton
🇺🇸Stockton, California, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
🇺🇸Valdosta, Georgia, United States
Shaw Cancer Center at Vail Valley Medical Center
🇺🇸Edwards, Colorado, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Good Samaritan Regional Health Center
🇺🇸Mt. Vernon, Illinois, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, 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 - 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 - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, 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
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Caritas Holy Family Hospital
🇺🇸Methuen, Massachusetts, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸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
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
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
🇺🇸Gape Girardeau, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸St. Louis, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, 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
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, 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
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
Center for Cancer Medicine and Blood Disorders, PA
🇺🇸El Paso, Texas, United States
Providence St. Peter Hospital Regional Cancer Center
🇺🇸Olympia, Washington, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Good Samaritan Cancer Center
🇺🇸Puyallup, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Aurora, Colorado, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, 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
Providence Cancer Center at Providence Portland Medical Center
🇺🇸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
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Roper St. Francis Cancer Center at Roper Hospital
🇺🇸Charleston, South Carolina, United States