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S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00107276
Recruitment Status : Completed
First Posted : April 6, 2005
Results First Posted : June 27, 2013
Last Update Posted : July 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: capecitabine Drug: cyclophosphamide Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer
Study Start Date : August 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: cyclophosphamide and capecitabine
cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Drug: capecitabine
Drug: cyclophosphamide
Other Name: cytoxan




Primary Outcome Measures :
  1. Response Rate (Complete and Partial, Confirmed and Unconfirmed) [ Time Frame: 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 :
  1. Progression-free Survival and Overall Survival [ Time Frame: 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.


  2. Toxicity [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107276


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Locations
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United States, Alaska
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
Providence Cancer Center
Anchorage, Alaska, United States, 99508
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Eden Medical Center
Castro Valley, California, United States, 94546
Kaiser Permanente - Fremont
Fremont, California, United States, 94538
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States, 94545
Saint Rose Hospital
Hayward, California, United States, 94545
Highland General Hospital
Oakland, California, United States, 94602
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States, 94611
Valley Care Medical Center
Pleasanton, California, United States, 94588
Kaiser Permanente Medical Center - Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente Medical Center - Richmond
Richmond, California, United States, 94801
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States, 95661
University of California Davis Cancer Center
Sacramento, California, United States, 95817
South Sacramento Kaiser-Permanente Medical Center
Sacramento, California, United States, 95823
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States, 94115
Kaiser Permanente Medical Center - Santa Teresa
San Jose, California, United States, 95119
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States, 94806
Kaiser Foundation Hospital - San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States, 95051
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California, United States, 95403
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States, 94080
Kaiser Permanente Medical Facility - Stockton
Stockton, California, United States, 95210
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States, 94589
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek, California, United States, 94596
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
Denver Health Medical Center
Denver, Colorado, United States, 80204
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
Shaw Cancer Center at Vail Valley Medical Center
Edwards, Colorado, United States, 81632
United States, Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, United States, 31603
United States, Illinois
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Good Samaritan Regional Health Center
Mt. Vernon, Illinois, United States, 62864
Edward Hospital Cancer Center
Naperville, Illinois, United States, 60540
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States, 67401
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States, 66604
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Massachusetts
Caritas Holy Family Hospital
Methuen, Massachusetts, United States, 01844
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
Mount Clemens, Michigan, United States, 48043
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Missouri
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States, 63701
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, United States, 63141
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Community Medical Center
Missoula, Montana, United States, 59801
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
United States, New York
Adirondack Cancer Care - Glens Falls
Glens Falls, New York, United States, 12801
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
MedCentral - Mansfield Hospital
Mansfield, Ohio, United States, 44903
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, South Carolina
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, United States, 29401
United States, Texas
Center for Cancer Medicine and Blood Disorders, PA
El Paso, Texas, United States, 79902
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Sandra L. Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Logan Regional Hospital
Logan, Utah, United States, 84321
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84103
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
United States, Washington
Auburn Regional Center for Cancer Care
Auburn, Washington, United States, 98002
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Providence Centralia Hospital
Centralia, Washington, United States, 98531-9027
St. Francis Hospital
Federal Way, Washington, United States, 98003
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Harborview Medical Center
Seattle, Washington, United States, 98104
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98112
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
Polyclinic First Hill
Seattle, Washington, United States, 98122
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
St. Joseph Medical Center at Franciscan Health System
Tacoma, Washington, United States, 98405-3004
Allenmore Hospital
Tacoma, Washington, United States, 98405
CCOP - Northwest
Tacoma, Washington, United States, 98405
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
St. Clare Hospital
Tacoma, Washington, United States, 98499
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
United States, West Virginia
United Hospital Center
Clarksburg, West Virginia, United States, 26301
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26102
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Anne F. Schott, MD University of Michigan Rogel Cancer Center
Study Chair: Kathy S. Albain, MD Loyola University

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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00107276     History of Changes
Other Study ID Numbers: CDR0000423180
S0430 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2005    Key Record Dates
Results First Posted: June 27, 2013
Last Update Posted: July 18, 2013
Last Verified: July 2013
Keywords provided by Southwest Oncology Group:
stage IV breast cancer
recurrent breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Capecitabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites