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AzTrials

Breast CancerPhase 2NCT00107276

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

A Phase 2 study testing capecitabine and cyclophosphamide in people with Breast Cancer, run by SWOG Cancer Research Network at 145 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
capecitabine and cyclophosphamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
145 sitesUnited States
Study dates
Aug 2005to Aug 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

145 sites in 1 country.

145 sites in 1 country

United States145 sites

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • American Fork Hospital

    American Fork, Utah, 84003

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Eden Medical Center

    Castro Valley, California, 94546

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • United Hospital Center

    Clarksburg, West Virginia, 26301

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Shaw Cancer Center at Vail Valley Medical Center

    Edwards, Colorado, 81632

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Center for Cancer Medicine and Blood Disorders, PA

    El Paso, Texas, 79902

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Gape Girardeau, Missouri, 63701

  • Adirondack Cancer Care - Glens Falls

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • Saint Rose Hospital

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Community Oncology Group at Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Logan Regional Hospital

    Logan, Utah, 84321

  • MedCentral - Mansfield Hospital

    Mansfield, Ohio, 44903

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Caritas Holy Family Hospital

    Methuen, Massachusetts, 01844

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Ted B. Wahby Cancer Center at Mount Clemens General Hospital

    Mount Clemens, Michigan, 48043

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Edward Hospital Cancer Center

    Naperville, Illinois, 60540

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Kaiser Permanente Medical Center - Oakland

    Oakland, California, 94611

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Valley Care Medical Center

    Pleasanton, California, 94588

  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • 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

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • South Sacramento Kaiser-Permanente Medical Center

    Sacramento, California, 95823

  • Kaiser Permanente Medical Center - Sacramento

    Sacramento, California, 95825

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Latter Day Saints Hospital

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Kaiser Permanente Medical Center - San Francisco Geary Campus

    San Francisco, California, 94115

  • Kaiser Permanente Medical Center - Santa Teresa

    San Jose, California, 95119

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

  • Kaiser Foundation Hospital - San Rafael

    San Rafael, California, 94903

  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus

    Santa Clara, California, 95051

  • Kaiser Permanente Medical Center - Santa Rosa

    Santa Rosa, California, 95403

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Kaiser Permanente Medical Center - South San Francisco

    South San Francisco, California, 94080

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Kaiser Permanente Medical Facility - Stockton

    Stockton, California, 95210

  • St. Joseph Medical Center at Franciscan Health System

    Tacoma, Washington, 98405-3004

  • Allenmore Hospital

    Tacoma, Washington, 98405

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • St. Clare Hospital

    Tacoma, Washington, 98499

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66604

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center

    Valdosta, Georgia, 31603

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • Kaiser Permanente Medical Center - Walnut Creek

    Walnut Creek, California, 94596

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Keywords
stage IV breast cancer, recurrent breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00107276
Study groupRoleWhat they receive
cyclophosphamide and capecitabineExperimentalcyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Receives: Drug: capecitabine; Drug: cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate (Complete and Partial, Confirmed and Unconfirmed)

    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.

    Measured: Patients assessed at least every six weeks while on protocol treatment

Secondary outcomes (2)

  1. Progression-free Survival and Overall Survival

    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.

    Measured: two years

  2. Toxicity

    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.

    Measured: Patients assessed after each 21-day cycle for 8 cycles (24 weeks of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionMar 2008
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00107276
Sponsor's protocol ID
CDR0000423180
Other IDs
S0430, U10CA032102
Status last verified
Jul 2013
First submitted
5 Apr 2005
Last updated
18 Jul 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine and cyclophosphamide in people with Breast Cancer, run by SWOG Cancer Research Network at 145 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (Complete and Partial, Confirmed and Unconfirmed) (time frame: Patients assessed at least every six weeks while on protocol treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00107276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2013.

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