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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
N/A
Not Enrolling
Female
Breast Cancer

Thank you

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 CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - NorthwestTacoma, Washington  98405-0986
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
University of California Davis Cancer CenterSacramento, California  95817
Kaiser Permanente Medical Center - San Francisco Geary CampusSan Francisco, California  94115
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Latter Day Saints HospitalSalt Lake City, Utah  84143
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Southwest Medical CenterLiberal, Kansas  67901
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
Kaiser Permanente Medical Center - SacramentoSacramento, California  95825
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Eden Medical CenterCastro Valley, California  94546
Kaiser Permanente - FremontFremont, California  94538
Saint Rose HospitalHayward, California  94545
Kaiser Permanente Medical Center - HaywardHayward, California  94545
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Valley Care Medical CenterPleasanton, California  94588
Kaiser Permanente Medical Center - Redwood CityRedwood City, California  94063
Kaiser Permanente Medical Center - RichmondRichmond, California  94801
Kaiser Permanente Medical Center - RosevilleRoseville, California  95661
South Sacramento Kaiser-Permanente Medical CenterSacramento, California  95823
Kaiser Permanente Medical Center - Santa TeresaSan Jose, California  95119
Kaiser Foundation Hospital - San RafaelSan Rafael, California  94903
Kaiser Permanente Medical Center - Santa RosaSanta Rosa, California  95403
Kaiser Permanente Medical Center - South San FranciscoSouth San Francisco, California  94080
Kaiser Permanente Medical Facility - StocktonStockton, California  95210
Kaiser Permanente Medical Center - Walnut CreekWalnut Creek, California  94596
Edward Hospital Cancer CenterNaperville, Illinois  60540
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Adirondack Cancer Care - Glens FallsGlens Falls, New York  12801
Iredell Memorial HospitalStatesville, North Carolina  28677
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Cleveland Clinic - WoosterWooster, Ohio  44691
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer CenterPortland, Oregon  97210
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Denver Health Medical CenterDenver, Colorado  80204-4507
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health SystemTacoma, Washington  98405-3004
Allenmore HospitalTacoma, Washington  98411-0414
Highland General HospitalOakland, California  94602
Pearlman Comprehensive Cancer Center at South Georgia Medical CenterValdosta, Georgia  31603
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
St. Joseph Cancer CenterBellingham, Washington  98225
Providence Centralia HospitalCentralia, Washington  98531-9027
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Community Comprehensive Cancer Center at Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Auburn Regional Center for Cancer CareAuburn, Washington  98002
MedCentral - Mansfield HospitalMansfield, Ohio  44903
Providence Cancer CenterAnchorage, Alaska  99508
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Ted B. Wahby Cancer Center at Mount Clemens General HospitalMount Clemens, Michigan  48043
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Shaw Cancer Center at Vail Valley Medical CenterEdwards, Colorado  81632
Caritas Holy Family HospitalMethuen, Massachusetts  01844
Center for Cancer Medicine and Blood Disorders, PAEl Paso, Texas  79902
United Hospital CenterClarksburg, West Virginia  26301