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

NCT00107276 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000423180S0430U10CA032102
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 145

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (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.

  Patients assessed at least every six weeks while on protocol treatment

Secondary Outcomes (2)

• Progression-free Survival and Overall Survival

  two years

• Toxicity

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

Study Arms (1)

cyclophosphamide and capecitabine

EXPERIMENTAL

cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each

Drug: capecitabine; Drug: cyclophosphamide

Interventions

capecitabine DRUG

cyclophosphamide and capecitabine

cyclophosphamide DRUG

Also known as: cytoxan

cyclophosphamide and capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (145)

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, 99508, United States

Location

Providence Cancer Center

Anchorage, Alaska, 99508, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Eden Medical Center

Castro Valley, California, 94546, United States

Location

Kaiser Permanente - Fremont

Fremont, California, 94538, United States

Location

Kaiser Permanente Medical Center - Hayward

Hayward, California, 94545, United States

Location

Saint Rose Hospital

Hayward, California, 94545, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, 94609, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Kaiser Permanente Medical Center - Oakland

Oakland, California, 94611, United States

Location

Valley Care Medical Center

Pleasanton, California, 94588, United States

Location

Kaiser Permanente Medical Center - Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente Medical Center - Richmond

Richmond, California, 94801, United States

Location

Kaiser Permanente Medical Center - Roseville

Roseville, California, 95661, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

South Sacramento Kaiser-Permanente Medical Center

Sacramento, California, 95823, United States

Location

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, 95825, United States

Location

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, 94115, United States

Location

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, 95119, United States

Location

Doctors Medical Center - San Pablo Campus

San Pablo, California, 94806, United States

Location

Kaiser Foundation Hospital - San Rafael

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente Medical Facility - Stockton

Stockton, California, 95210, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, 94596, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Shaw Cancer Center at Vail Valley Medical Center

Edwards, Colorado, 81632, United States

Location

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

Savannah, Georgia, 31403-3089, United States

Location

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Valdosta, Georgia, 31603, United States

Location

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

Alton, Illinois, 62002, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Edward Hospital Cancer Center

Naperville, Illinois, 60540, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

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

Kansas City, Kansas, 66160-7357, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cotton-O'Neil Cancer Center

Topeka, Kansas, 66604, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Caritas Holy Family Hospital

Methuen, Massachusetts, 01844, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, 48910, United States

Location

Ted B. Wahby Cancer Center at Mount Clemens General Hospital

Mount Clemens, Michigan, 48043, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Gape Girardeau, Missouri, 63701, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Saint Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

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

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405-5309, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

Unknown Facility

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology at KRMC

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

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

Missoula, Montana, 59807, United States

Location

Adirondack Cancer Care - Glens Falls

Glens Falls, New York, 12801, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

MedCentral - Mansfield Hospital

Mansfield, Ohio, 44903, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, 97227, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

Roper St. Francis Cancer Center at Roper Hospital

Charleston, South Carolina, 29401, United States

Location

Center for Cancer Medicine and Blood Disorders, PA

El Paso, Texas, 79902, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Sandra L. Maxwell Cancer Center

Cedar City, Utah, 84720, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, 84157, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Latter Day Saints Hospital

Salt Lake City, Utah, 84103, United States

Location

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, 84106, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

Auburn Regional Center for Cancer Care

Auburn, Washington, 98002, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Providence Centralia Hospital

Centralia, Washington, 98531-9027, United States

Location

St. Francis Hospital

Federal Way, Washington, 98003, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98273, United States

Location

Providence St. Peter Hospital Regional Cancer Center

Olympia, Washington, 98506-5166, United States

Location

Good Samaritan Cancer Center

Puyallup, Washington, 98372, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Polyclinic First Hill

Seattle, Washington, 98122, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

St. Joseph Medical Center at Franciscan Health System

Tacoma, Washington, 98405-3004, United States

Location

Allenmore Hospital

Tacoma, Washington, 98405, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405, United States

Location

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

St. Clare Hospital

Tacoma, Washington, 98499, United States

Location

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, 98668, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801-2028, United States

Location

United Hospital Center

Clarksburg, West Virginia, 26301, United States

Location

Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

Parkersburg, West Virginia, 26102, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Study statistician
• Organization: SWOG

206-667-4623

Study Officials

• Anne F. Schott, MD

  University of Michigan Rogel Cancer Center

  STUDY CHAIR

• Kathy S. Albain, MD

  Loyola University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2005
• First Posted: April 6, 2005
• Study Start: August 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: August 1, 2009
• Last Updated: July 18, 2013
• Results First Posted: June 27, 2013

Record last verified: 2013-07

Locations

US (145)