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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00107276
First received: April 5, 2005
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Breast Cancer
Drug: capecitabine
Drug: cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Response Rate (Complete and Partial, Confirmed and Unconfirmed) [ Time Frame: Patients assessed at least every six weeks while on protocol treatment ] [ Designated as safety issue: No ]
    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:
  • Progression-free Survival and Overall Survival [ Time Frame: two years ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 112
Study Start Date: August 2005
Study Completion Date: August 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107276

  Show 145 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Anne F. Schott, MD University of Michigan Cancer Center
Study Chair: Kathy S. Albain, MD Loyola University
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00107276     History of Changes
Other Study ID Numbers: CDR0000423180, S0430, U10CA032102
Study First Received: April 5, 2005
Results First Received: November 15, 2012
Last Updated: July 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Capecitabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on September 18, 2014