Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
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:
No
Principal Investigator
Anne F. Schott, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Michigan Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000423180
NCT ID:
NCT00107276
Start Date:
August 2005
Completion Date:
August 2009
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| 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 |
