Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE April 5, 2005
First Posted Date  ICMJE April 6, 2005
Results First Submitted Date  ICMJE November 15, 2012
Results First Posted Date  ICMJE June 27, 2013
Last Update Posted Date July 18, 2013
Study Start Date  ICMJE August 2005
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2013)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00107276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer
Official Title  ICMJE Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: capecitabine
  • Drug: cyclophosphamide
    Other Name: cytoxan
Study Arms  ICMJE Experimental: cyclophosphamide and capecitabine
cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Interventions:
  • Drug: capecitabine
  • Drug: cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2012)
112
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00107276
Other Study ID Numbers  ICMJE CDR0000423180
S0430 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor  ICMJE Southwest Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Anne F. Schott, MD University of Michigan Rogel Cancer Center
Study Chair: Kathy S. Albain, MD Loyola University
PRS Account Southwest Oncology Group
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP