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Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer


- 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.

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



- 18 and over


- Female

Menopausal status

- Not specified

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- No known existing uncontrolled coagulopathy


- Not specified


- Creatinine clearance > 40 mL/min


- 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


- Able to take oral medication

- No uncontrolled nausea, vomiting, or diarrhea

- No lack of physical integrity of the upper gastrointestinal tract

- No malabsorption syndrome


- 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


Biologic therapy

- No concurrent immunotherapy or biologic therapy for breast cancer

- No concurrent gene therapy for breast cancer

- No concurrent filgrastim (G-CSF)


- 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


- See Disease Characteristics

- At least 14 days since prior radiotherapy to non-CNS disease sites and recovered

- No concurrent radiotherapy for breast cancer


- Not specified


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate (Complete and Partial, Confirmed and Unconfirmed)

Outcome Description:

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.

Outcome Time Frame:

Patients assessed at least every six weeks while on protocol treatment

Safety Issue:


Principal Investigator

Anne F. Schott, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2005

Completion Date:

August 2009

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbia River Oncology Program Portland, Oregon  97225
MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma, Washington  98405
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
CCOP - Northwest Tacoma, Washington  98405-0986
Kaiser Permanente Medical Center - Vallejo Vallejo, California  94589
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
University of California Davis Cancer Center Sacramento, California  95817
Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco, California  94115
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Latter Day Saints Hospital Salt Lake City, Utah  84143
Kaiser Permanente Medical Center - Oakland Sacramento, California  95825
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Alaska Regional Hospital Cancer Center Anchorage, Alaska  99508
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
Southwest Medical Center Liberal, Kansas  67901
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Gape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Kaiser Permanente Medical Center - Santa Clara Kiely Campus Santa Clara, California  95051-5386
Kaiser Permanente Medical Center - Sacramento Sacramento, California  95825
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Eden Medical Center Castro Valley, California  94546
Kaiser Permanente - Fremont Fremont, California  94538
Saint Rose Hospital Hayward, California  94545
Kaiser Permanente Medical Center - Hayward Hayward, California  94545
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Valley Care Medical Center Pleasanton, California  94588
Kaiser Permanente Medical Center - Redwood City Redwood City, California  94063
Kaiser Permanente Medical Center - Richmond Richmond, California  94801
Kaiser Permanente Medical Center - Roseville Roseville, California  95661
South Sacramento Kaiser-Permanente Medical Center Sacramento, California  95823
Kaiser Permanente Medical Center - Santa Teresa San Jose, California  95119
Kaiser Foundation Hospital - San Rafael San Rafael, California  94903
Kaiser Permanente Medical Center - Santa Rosa Santa Rosa, California  95403
Kaiser Permanente Medical Center - South San Francisco South San Francisco, California  94080
Kaiser Permanente Medical Facility - Stockton Stockton, California  95210
Kaiser Permanente Medical Center - Walnut Creek Walnut Creek, California  94596
Edward Hospital Cancer Center Naperville, Illinois  60540
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Adirondack Cancer Care - Glens Falls Glens Falls, New York  12801
Iredell Memorial Hospital Statesville, North Carolina  28677
Community Oncology Group at Cleveland Clinic Cancer Center Independence, Ohio  44131
Cleveland Clinic - Wooster Wooster, Ohio  44691
Legacy Mount Hood Medical Center Gresham, Oregon  97030
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center Portland, Oregon  97210
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Legacy Meridian Park Hospital Tualatin, Oregon  97062
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Denver Health Medical Center Denver, Colorado  80204-4507
St. Francis Hospital Federal Way, Washington  98003
St. Clare Hospital Lakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer Center Olympia, Washington  98506
Good Samaritan Cancer Center Puyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health System Tacoma, Washington  98405-3004
Allenmore Hospital Tacoma, Washington  98411-0414
Highland General Hospital Oakland, California  94602
Pearlman Comprehensive Cancer Center at South Georgia Medical Center Valdosta, Georgia  31603
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cotton-O'Neil Cancer Center Topeka, Kansas  66606
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
St. Joseph Cancer Center Bellingham, Washington  98225
Providence Centralia Hospital Centralia, Washington  98531-9027
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg, West Virginia  26102
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Auburn Regional Center for Cancer Care Auburn, Washington  98002
MedCentral - Mansfield Hospital Mansfield, Ohio  44903
Providence Cancer Center Anchorage, Alaska  99508
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Ted B. Wahby Cancer Center at Mount Clemens General Hospital Mount Clemens, Michigan  48043
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Shaw Cancer Center at Vail Valley Medical Center Edwards, Colorado  81632
Caritas Holy Family Hospital Methuen, Massachusetts  01844
Center for Cancer Medicine and Blood Disorders, PA El Paso, Texas  79902
United Hospital Center Clarksburg, West Virginia  26301